{"id":1036,"date":"2023-09-25T10:39:02","date_gmt":"2023-09-25T09:39:02","guid":{"rendered":"https:\/\/www.consultlhasa.com\/?page_id=1036"},"modified":"2026-08-07T16:13:41","modified_gmt":"2026-08-07T15:13:41","slug":"non-mutagenic-impurities","status":"publish","type":"page","link":"https:\/\/www.consultlhasa.com\/es\/our-services\/non-mutagenic-impurities\/","title":{"rendered":"Impurezas no mutag\u00e9nicas"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1036\" class=\"elementor elementor-1036\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-71bf4ac elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"71bf4ac\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[],&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9e2bb3f\" data-id=\"9e2bb3f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-cc1c0a4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"cc1c0a4\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-4d626a3\" data-id=\"4d626a3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-ecd9a6d\" data-id=\"ecd9a6d\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fa2c14b elementor-widget elementor-widget-heading\" data-id=\"fa2c14b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Non-mutagenic impurities<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-922a7f0 elementor-widget elementor-widget-heading\" data-id=\"922a7f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Supporting the assessment and control of your non-mutagenic impurities and contaminants <\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-386378a\" data-id=\"386378a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-9517bc7 elementor-widget elementor-widget-spacer\" data-id=\"9517bc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-870a7c5 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"870a7c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.consultlhasa.com\/contact-us\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Get in touch<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8d5d073 elementor-widget elementor-widget-spacer\" data-id=\"8d5d073\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0d43e60 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"0d43e60\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5c8f352 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5c8f352\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-d444f29\" data-id=\"d444f29\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-054f71d elementor-widget elementor-widget-menu-anchor\" data-id=\"054f71d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"CL-non-mutagenic-impurities-form\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2407595 elementor-widget elementor-widget-heading\" data-id=\"2407595\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Assessment and control of non-mutagenic impurities and contaminants<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-658c172 elementor-widget elementor-widget-text-editor\" data-id=\"658c172\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>If an impurity is known to be non-mutagenic or non-carcinogenic, impurity levels in the active pharmaceutical ingredient (API) and drug product, still need to be assessed and controlled.<\/p><p>Additionally, the potential for cross-contamination in shared API manufacturing facilities must be evaluated based on the risk posed by identified cross contaminants.<\/p><p>Regulatory guidelines require careful evaluation of impurity thresholds to demonstrate that exposure is within acceptable limits and will be safe for human exposure.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-1b03407\" data-id=\"1b03407\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e337287 elementor-widget elementor-widget-global elementor-global-2396 elementor-widget-html\" data-id=\"e337287\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<script src=\"https:\/\/js-eu1.hsforms.net\/forms\/embed\/147317948.js\" defer><\/script>\r\n<div class=\"hs-form-frame\" data-region=\"eu1\" data-form-id=\"a022f0e3-73a1-4ed3-819c-cd65e35d0045\" data-portal-id=\"147317948\"><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-20cde70 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"20cde70\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b908ee4\" data-id=\"b908ee4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9ebaf40 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"9ebaf40\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b4fa313 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b4fa313\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-07d8fa0\" data-id=\"07d8fa0\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9d0d7e5 elementor-widget elementor-widget-spacer\" data-id=\"9d0d7e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-5aac5d8\" data-id=\"5aac5d8\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-765ef56 elementor-widget elementor-widget-heading\" data-id=\"765ef56\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why choose Consult Lhasa?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3258a03 elementor-widget elementor-widget-text-editor\" data-id=\"3258a03\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Consult Lhasa provide expert risk assessments for non-mutagenic impurities and cross contaminants, built on Lhasa Limited science, that can be trusted by industry and regulatory authorities.<\/p><p>If you need assistance with your non-mutagenic impurity risk assessment, <a href=\"https:\/\/www.consultlhasa.com\/contact-us\"><strong>Consult Lhasa<\/strong><\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-12bd6a1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"12bd6a1\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ec221fa\" data-id=\"ec221fa\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9f1dd4c elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"9f1dd4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-099b6a3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"099b6a3\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4d7d9b9\" data-id=\"4d7d9b9\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9b5115b elementor-widget elementor-widget-heading\" data-id=\"9b5115b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How can our experts help you to assess\n<br>non-mutagenic impurities?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b53662c elementor-widget elementor-widget-jet-accordion\" data-id=\"b53662c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"jet-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"jet-accordion\" data-settings=\"{&quot;collapsible&quot;:false,&quot;ajaxTemplate&quot;:false,&quot;switchScrolling&quot;:false,&quot;switchScrollingTablet&quot;:false,&quot;switchScrollingMobile&quot;:false,&quot;switchScrollingOffset&quot;:{&quot;size&quot;:0,&quot;unit&quot;:&quot;px&quot;},&quot;switchScrollingOffsetTablet&quot;:{&quot;size&quot;:0,&quot;unit&quot;:&quot;px&quot;},&quot;switchScrollingOffsetMobile&quot;:{&quot;size&quot;:0,&quot;unit&quot;:&quot;px&quot;},&quot;switchScrollingDelay&quot;:500,&quot;switchScrollingDelayTablet&quot;:500,&quot;switchScrollingDelayMobile&quot;:500}\">\n\t\t\t<div class=\"jet-accordion__inner\">\n\t\t\t\t<div class=\" jet-accordion__item jet-toggle jet-toggle-move-up-effect \">\n\t\t\t\t\t\t\t<div id=\"non-mutagenic-impurity-qualification\" class=\"jet-toggle__control elementor-menu-anchor\" data-toggle=\"1\" role=\"button\" tabindex=\"0\" aria-controls=\"jet-toggle-content-1901\" aria-expanded=\"false\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__label-icon jet-toggle-icon-position-right\"><span class=\"jet-toggle__icon icon-normal jet-tabs-icon\"><i class=\"fas fa-caret-down\"><\/i><\/span><span class=\"jet-toggle__icon icon-active jet-tabs-icon\"><i class=\"fas fa-caret-up\"><\/i><\/span><\/div><div class=\"jet-toggle__label-text\">Non-mutagenic impurity qualification<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div id=\"jet-toggle-content-1901\" class=\"jet-toggle__content\" data-toggle=\"1\" role=\"region\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__content-inner\"><hr style=\"margin: 0 0 20px;\" \/>\n\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need to qualify a non-mutagenic impurity above the ICH Q3A or Q3B qualification threshold?<\/p>\n<p style=\"margin: 0;\">When a non-mutagenic, or non-genotoxic impurity (NGI), exceeds the relevant qualification threshold, additional evidence may be needed to demonstrate that exposure at the observed level is toxicologically acceptable. We can assess the available evidence and product context to help determine the most appropriate route to qualification.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Could your impurity be qualified using existing evidence?<\/p>\n<p style=\"margin: 0;\">Before progressing to more complex assessments, existing information may provide a route to qualification. For example, an impurity may be a significant metabolite of the API or sufficiently comparable to the API to support a toxicological justification. We can evaluate the available evidence, including exposure and safety considerations, to determine whether it can support qualification.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need a scientifically justified read-across assessment?<\/p>\n<p style=\"margin: 0;\">Where direct toxicological data are limited, read-across may provide an appropriate route to qualification. We can identify potential surrogate compounds and assess their structural, biological and toxicological relevance to determine whether they can support your impurity assessment. We will provide a clear expert justification for analogue selection and its use within the wider weight of evidence.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Could computational approaches or New Approach Methodologies (NAMs) strengthen your assessment?<\/p>\n<p style=\"margin: 0;\">Where existing evidence does not provide a clear answer, computational approaches can provide additional information on relevant toxicity endpoints. We can interpret in silico evidence alongside exposure, experimental data and other available information to strengthen a proportionate, evidence-based qualification strategy.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 0;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need to bring the evidence together into a clear weight-of-evidence (WoE) justification?<\/p>\n<p style=\"margin: 0;\">Individual pieces of evidence need to be interpreted in the context of the impurity, exposure and overall safety profile. We can bring the available evidence together into a transparent WoE assessment, identifying any remaining gaps and providing a clear scientific rationale to support your qualification decision.<\/p>\n\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div><div class=\" jet-accordion__item jet-toggle jet-toggle-move-up-effect \">\n\t\t\t\t\t\t\t<div id=\"residual-solvents\" class=\"jet-toggle__control elementor-menu-anchor\" data-toggle=\"2\" role=\"button\" tabindex=\"0\" aria-controls=\"jet-toggle-content-1902\" aria-expanded=\"false\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__label-icon jet-toggle-icon-position-right\"><span class=\"jet-toggle__icon icon-normal jet-tabs-icon\"><i class=\"fas fa-caret-down\"><\/i><\/span><span class=\"jet-toggle__icon icon-active jet-tabs-icon\"><i class=\"fas fa-caret-up\"><\/i><\/span><\/div><div class=\"jet-toggle__label-text\">Residual solvents<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div id=\"jet-toggle-content-1902\" class=\"jet-toggle__content\" data-toggle=\"2\" role=\"region\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__content-inner\"><hr style=\"margin: 0 0 20px;\" \/>\n\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Is your residual solvent not covered by ICH Q3C?<\/p>\n<p style=\"margin: 0;\">Not every solvent used in pharmaceutical development or manufacture has an established permitted daily exposure (PDE) in ICH Q3C. Where no recognised limit is available, we can assess the available toxicological evidence and determine the most appropriate approach for establishing a scientifically justified exposure limit.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need to establish a PDE for your residual solvent?<\/p>\n<p style=\"margin: 0;\">Where sufficient toxicological data are available, we can identify the critical effects and appropriate point of departure and use these to derive a PDE for your solvent. This provides a clear toxicological basis for assessing whether the proposed level of exposure is acceptable.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">What if there is not enough data to derive a solvent-specific PDE?<\/p>\n<p style=\"margin: 0;\">Limited data do not necessarily mean the assessment has to stop. Where appropriate, we can identify suitable surrogate compounds and use read-across to determine whether existing toxicological evidence can support an acceptable exposure level for your solvent.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 0;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need help applying the derived limit within your risk assessment?<\/p>\n<p style=\"margin: 0;\">We can help interpret the outcome of the toxicological assessment, explain the basis for the proposed limit and support how it is applied within your wider risk assessment and regulatory justification.<\/p>\n\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div><div class=\" jet-accordion__item jet-toggle jet-toggle-move-up-effect \">\n\t\t\t\t\t\t\t<div id=\"elemental-impurities\" class=\"jet-toggle__control elementor-menu-anchor\" data-toggle=\"3\" role=\"button\" tabindex=\"0\" aria-controls=\"jet-toggle-content-1903\" aria-expanded=\"false\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__label-icon jet-toggle-icon-position-right\"><span class=\"jet-toggle__icon icon-normal jet-tabs-icon\"><i class=\"fas fa-caret-down\"><\/i><\/span><span class=\"jet-toggle__icon icon-active jet-tabs-icon\"><i class=\"fas fa-caret-up\"><\/i><\/span><\/div><div class=\"jet-toggle__label-text\">Elemental impurities<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div id=\"jet-toggle-content-1903\" class=\"jet-toggle__content\" data-toggle=\"3\" role=\"region\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__content-inner\"><hr style=\"margin: 0 0 20px;\" \/>\n\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need to assess the risk of elemental impurities in your drug product?<\/p>\n<p style=\"margin: 0;\">Elemental impurities can enter a drug product from multiple sources, including raw materials, excipients, manufacturing equipment and container closure systems. We can help you identify relevant sources, assess their potential contribution and evaluate the overall risk in line with ICH Q3D.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Are you unsure whether the level of an elemental impurity is acceptable?<\/p>\n<p style=\"margin: 0;\">We can evaluate estimated or measured exposure against the relevant permitted daily exposure (PDE), taking account of the route of administration and contributions from different components of the drug product. This can help determine which elemental impurities require further consideration and whether additional controls may be needed.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 24px;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need to determine whether additional controls are required?<\/p>\n<p style=\"margin: 0;\">Not every identified source of an elemental impurity requires additional control. We can interpret the available data and overall risk assessment to help determine whether existing controls are sufficient or whether further monitoring, specification or other measures should be considered.<\/p>\n\n<\/div>\n<div style=\"margin-bottom: 0;\">\n<p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need support developing and justifying an elemental impurity control strategy?<\/p>\n<p style=\"margin: 0;\">Where additional controls are appropriate, we can help develop a proportionate control strategy based on the identified sources, estimated or measured exposure and existing manufacturing controls. We can bring the evidence together into a clear scientific justification for the proposed approach, supporting your wider risk assessment and regulatory documentation.<\/p>\n\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div><div class=\" jet-accordion__item jet-toggle jet-toggle-move-up-effect \">\n\t\t\t\t\t\t\t<div id=\"health-based-exposure-limits\" class=\"jet-toggle__control elementor-menu-anchor\" data-toggle=\"4\" role=\"button\" tabindex=\"0\" aria-controls=\"jet-toggle-content-1904\" aria-expanded=\"false\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__label-icon jet-toggle-icon-position-right\"><span class=\"jet-toggle__icon icon-normal jet-tabs-icon\"><i class=\"fas fa-caret-down\"><\/i><\/span><span class=\"jet-toggle__icon icon-active jet-tabs-icon\"><i class=\"fas fa-caret-up\"><\/i><\/span><\/div><div class=\"jet-toggle__label-text\">Health based exposure limits (HBELs)<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div id=\"jet-toggle-content-1904\" class=\"jet-toggle__content\" data-toggle=\"4\" role=\"region\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__content-inner\"><hr style=\"margin: 0 0 20px;\" \/>\n\n<div style=\"margin-bottom: 24px;\">\n  <p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need to derive or assess a health-based exposure limit (HBEL)?<\/p>\n  <p style=\"margin: 0;\">Where an appropriate exposure limit is not already available, we can review the toxicological evidence and help derive or assess values such as occupational exposure limits (OELs) or other HBELs, depending on the intended use and exposure scenario.<\/p>\n<\/div>\n\n<div style=\"margin-bottom: 24px;\">\n  <p style=\"font-weight: bold; margin: 0 0 6px;\">Are you unsure whether the selected point of departure and calculation approach are appropriate?<\/p>\n  <p style=\"margin: 0;\">The choice of point of departure can have a significant influence on the resulting limit. We can review the critical toxicological effects, study selection, adjustment factors and calculation approach to determine whether the proposed derivation is scientifically appropriate and proportionate.<\/p>\n<\/div>\n\n<div style=\"margin-bottom: 24px;\">\n  <p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need a clear scientific and regulatory justification for the selected limit?<\/p>\n  <p style=\"margin: 0;\">A defensible HBEL requires more than a final numerical value. We can bring together the relevant toxicological evidence, explain the basis for key decisions and provide a transparent rationale for the selected limit to support internal review and regulatory documentation.<\/p>\n<\/div>\n\n<div style=\"margin-bottom: 0;\">\n  <p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need support responding to comments or finalising your assessment?<\/p>\n  <p style=\"margin: 0;\">Questions can arise as an assessment moves through internal, customer or regulatory review. We can help address scientific comments, revise the assessment where appropriate and ensure the final report clearly explains the evidence, assumptions and rationale behind the resulting exposure limit.<\/p>\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div><div class=\" jet-accordion__item jet-toggle jet-toggle-move-up-effect \">\n\t\t\t\t\t\t\t<div id=\"carcinogenicity-assessment\" class=\"jet-toggle__control elementor-menu-anchor\" data-toggle=\"5\" role=\"button\" tabindex=\"0\" aria-controls=\"jet-toggle-content-1905\" aria-expanded=\"false\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__label-icon jet-toggle-icon-position-right\"><span class=\"jet-toggle__icon icon-normal jet-tabs-icon\"><i class=\"fas fa-caret-down\"><\/i><\/span><span class=\"jet-toggle__icon icon-active jet-tabs-icon\"><i class=\"fas fa-caret-up\"><\/i><\/span><\/div><div class=\"jet-toggle__label-text\">Carcinogenicity<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div id=\"jet-toggle-content-1905\" class=\"jet-toggle__content\" data-toggle=\"5\" role=\"region\" data-template-id=\"false\">\n\t\t\t\t\t\t\t\t<div class=\"jet-toggle__content-inner\"><hr style=\"margin: 0 0 20px;\" \/><div style=\"margin-bottom: 24px;\"><p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need to understand carcinogenicity risk earlier in development?<\/p><p style=\"margin: 0;\">Carcinogenicity risk may need to be considered before the full non-clinical package is available. Early assessment gives you a clearer view of what is already known, what is uncertain and what evidence may be needed as the programme progresses. We review available <em>in vitro<\/em> data, computational toxicology predictions and relevant literature to provide an early scientific view on potential carcinogenicity concerns and the next steps to consider.<\/p><\/div><div style=\"margin-bottom: 24px;\"><p style=\"font-weight: bold; margin: 0 0 6px;\">Has an unexpected or borderline finding raised a carcinogenicity question?<\/p><p style=\"margin: 0;\">Not every finding that raises concern will indicate a meaningful carcinogenic risk. Borderline, unexpected or difficult-to-interpret results need to be assessed quickly so they do not delay decisions or drive unnecessary follow-up work. We review the finding in context, assess whether it is biologically meaningful and explain what weight it should carry in the wider carcinogenicity assessment.<\/p><\/div><div style=\"margin-bottom: 24px;\"><p style=\"font-weight: bold; margin: 0 0 6px;\">Could your API\u2019s target or off-target activity plausibly contribute to cancer risk?<\/p><p style=\"margin: 0;\">Carcinogenicity risk may be linked to the primary biological target, secondary pharmacology or other biological activity. These signals need to be interpreted in the context of target function, pathway relevance, cancer biology and available supporting evidence. We review target-related evidence, off-target activity, computational predictions and relevant literature to assess whether a plausible carcinogenic mode of action is supported and how this evidence contributes to the wider assessment.<\/p><\/div><div style=\"margin-bottom: 24px;\"><p style=\"font-weight: bold; margin: 0 0 6px;\">Do your genotoxicity or other study findings need explaining in a human-relevant context?<\/p><p style=\"margin: 0;\">Genotoxicity, repeat-dose toxicity, histopathology, hormonal activity or immune modulation findings can raise questions about carcinogenic potential. These findings are not always straightforward to interpret, particularly when their relevance to humans is uncertain. We assess whether the findings support a potential carcinogenic mechanism, how they fit with the wider evidence package and whether further clarification is needed, so the significance of the finding is understood rather than treated in isolation.<\/p><\/div><div style=\"margin-bottom: 24px;\"><p style=\"font-weight: bold; margin: 0 0 6px;\">Do you need to justify your carcinogenicity testing strategy with a clear weight-of-evidence rationale?<\/p><p style=\"margin: 0;\">Under ICH S1B(R1), a weight-of-evidence approach can support decisions on whether further carcinogenicity testing, including a 2-year rat carcinogenicity study, is scientifically justified. This requires a clear explanation of what the evidence shows, how uncertainty has been handled and why the conclusion is appropriate. We bring together biological, toxicological, computational, and literature-based evidence into a structured carcinogenicity weight-of-evidence narrative, with an expert rationale that explains the conclusion, confidence in the evidence, human relevance, and recommended next steps.<\/p><\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4e27a9d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4e27a9d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5e90410\" data-id=\"5e90410\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4e67052 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"4e67052\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7edc07a elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7edc07a\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[],&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-87fab83\" data-id=\"87fab83\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6946792 elementor-widget elementor-widget-heading\" data-id=\"6946792\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">We provide regulatory support<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-062689d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"062689d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-narrow\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-94a503f\" data-id=\"94a503f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6a619ec elementor-flip-box--effect-flip elementor-flip-box--direction-up elementor-widget elementor-widget-flip-box\" data-id=\"6a619ec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__image\">\n\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"177\" height=\"177\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/08\/ich-q3a.svg\" class=\"attachment-full size-full wp-image-674\" alt=\"ICH Q3A\" \/>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\tDiscover more\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\tICH Q3A\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tFor qualification of new drug substances produced by chemical synthesis.\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-dc62c89\" data-id=\"dc62c89\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3555fe3 elementor-flip-box--effect-flip elementor-flip-box--direction-up elementor-widget elementor-widget-flip-box\" data-id=\"3555fe3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__image\">\n\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"177\" height=\"177\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/08\/ich-q3b.svg\" class=\"attachment-full size-full wp-image-676\" alt=\"\" \/>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\tDiscover more\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\tICH Q3B\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tFor qualification of impurities in new drug substances produced by chemical syntheses.\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-180ad9f\" data-id=\"180ad9f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a49f3f0 elementor-flip-box--effect-flip elementor-flip-box--direction-up elementor-widget elementor-widget-flip-box\" data-id=\"a49f3f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__image\">\n\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"177\" height=\"177\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/09\/ich-q3c.svg\" class=\"attachment-full size-full wp-image-1118\" alt=\"\" \/>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\tDiscover more\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\tICH Q3C\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tFor classifying solvents into one of three classifications, and associating safe limits. \t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-97f5ae5\" data-id=\"97f5ae5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3e8e36e elementor-flip-box--effect-flip elementor-flip-box--direction-up elementor-widget elementor-widget-flip-box\" data-id=\"3e8e36e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__image\">\n\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"177\" height=\"177\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/09\/ich-q3d.svg\" class=\"attachment-full size-full wp-image-1117\" alt=\"\" \/>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\tDiscover more\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\tICH Q3D\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tFor assessing and controlling elemental impurities in the drug product, using a risk-based control strategy.\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d0debae elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d0debae\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-526da56\" data-id=\"526da56\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3876b37 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"3876b37\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" d=\"m55.51,63.64L103.25,7.25c2.42-2.86.39-7.25-3.36-7.25H4.41C.66,0-1.37,4.39,1.05,7.25l47.74,56.39c1.76,2.08,4.96,2.08,6.72,0Z\"><\/path><\/g><\/svg><\/div>\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-519b63c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"519b63c\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-27b31df\" data-id=\"27b31df\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6faa021 elementor-arrows-position-inside elementor-widget elementor-widget-global elementor-global-2143 elementor-widget-loop-carousel\" data-id=\"6faa021\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:1885,&quot;slides_to_show&quot;:&quot;1&quot;,&quot;slides_to_show_tablet&quot;:&quot;1&quot;,&quot;slides_to_show_laptop&quot;:&quot;1&quot;,&quot;slides_to_show_tablet_extra&quot;:&quot;1&quot;,&quot;_skin&quot;:&quot;post&quot;,&quot;slides_to_show_mobile&quot;:&quot;1&quot;,&quot;slides_to_scroll&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;.elementor-loop-container&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;autoplay_speed&quot;:5000,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;speed&quot;:500,&quot;offset_sides&quot;:&quot;none&quot;,&quot;arrows&quot;:&quot;yes&quot;,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;image_spacing_custom_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet_extra&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-carousel.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"swiper elementor-loop-container elementor-grid\" role=\"list\" dir=\"ltr\">\n\t\t\t\t<div class=\"swiper-wrapper\" aria-live=\"off\">\n\t\t<style id=\"loop-1885\">.elementor-1885 .elementor-element.elementor-element-7e552b6{margin-top:30px;margin-bottom:30px;}.elementor-bc-flex-widget .elementor-1885 .elementor-element.elementor-element-169dc22.elementor-column .elementor-widget-wrap{align-items:center;}.elementor-1885 .elementor-element.elementor-element-169dc22.elementor-column.elementor-element[data-element_type=\"column\"] > .elementor-widget-wrap.elementor-element-populated{align-content:center;align-items:center;}.elementor-1885 .elementor-element.elementor-element-169dc22 > .elementor-element-populated{margin:0px 0px 0px 20px;--e-column-margin-right:0px;--e-column-margin-left:20px;}.elementor-widget-theme-post-content{color:var( --e-global-color-text );font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-weight:var( --e-global-typography-text-font-weight );}.elementor-1885 .elementor-element.elementor-element-9839265{text-align:start;color:#1D1D1B;font-family:\"Inter\", Sans-serif;font-size:20px;font-style:italic;line-height:24px;letter-spacing:0px;}.elementor-widget-theme-post-title .elementor-heading-title{font-family:var( --e-global-typography-primary-font-family ), Sans-serif;color:var( --e-global-color-primary );}.elementor-1885 .elementor-element.elementor-element-2397f38{text-align:start;}.elementor-1885 .elementor-element.elementor-element-2397f38 .elementor-heading-title{font-family:\"Inter\", Sans-serif;font-size:20px;font-weight:700;font-style:italic;line-height:24px;letter-spacing:0px;color:#1D1D1B;}.elementor-bc-flex-widget .elementor-1885 .elementor-element.elementor-element-22125ee.elementor-column .elementor-widget-wrap{align-items:center;}.elementor-1885 .elementor-element.elementor-element-22125ee.elementor-column.elementor-element[data-element_type=\"column\"] > .elementor-widget-wrap.elementor-element-populated{align-content:center;align-items:center;}.elementor-widget-image .widget-image-caption{color:var( --e-global-color-text );font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-weight:var( --e-global-typography-text-font-weight );}.elementor-1885 .elementor-element.elementor-element-f2a53c7 .elementor-wrapper{--video-aspect-ratio:1.77777;}@media(max-width:767px){.elementor-1885 .elementor-element.elementor-element-9839265{font-size:16px;}.elementor-1885 .elementor-element.elementor-element-2397f38 .elementor-heading-title{font-size:16px;}}<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"1885\" class=\"elementor elementor-1885 swiper-slide e-loop-item e-loop-item-1884 post-1884 testimonial type-testimonial status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" role=\"group\" aria-roledescription=\"slide\" data-custom-edit-handle=\"1\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7e552b6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7e552b6\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-169dc22\" data-id=\"169dc22\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9839265 elementor-widget elementor-widget-theme-post-content\" data-id=\"9839265\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-content.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p>&#8220;Our experience with Consult Lhasa has been very positive, resulting in a final report that we are confident will meet the scope required by regulatory agencies. The Consult Lhasa team are knowledgeable about the regulatory needs of the region, particularly Brazil, and provide great support. Their consulting has been invaluable to our company, the technical, scientific and human exchange has been impeccable. We are very satisfied with the collaboration.&#8221;<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2397f38 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2397f38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Adriana Tomalino, Head of Regulatory Affairs at Triquim<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-22125ee\" data-id=\"22125ee\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa07a5b elementor-widget elementor-widget-image\" data-id=\"aa07a5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image.png\" class=\"attachment-full size-full wp-image-1833\" alt=\"Adriana Tomalino testimonial image\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image.png 1080w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image-1024x1024.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/11\/Adriana-Tomalino-testimonial-image-768x768.png 768w\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"1885\" class=\"elementor elementor-1885 swiper-slide e-loop-item e-loop-item-2763 post-2763 testimonial type-testimonial status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" role=\"group\" aria-roledescription=\"slide\" data-custom-edit-handle=\"1\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7e552b6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7e552b6\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-169dc22\" data-id=\"169dc22\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9839265 elementor-widget elementor-widget-theme-post-content\" data-id=\"9839265\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-content.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p>&#8220;We recently had the experience of collaborating with Consult Lhasa to address an EU regulatory deficiency on a potential degradation impurity of the drug substance. Consult Lhasa made an intriguing task look simple in the final report which was based on Zeneth, literature review and expert analysis. Their professionalism and commitment to excellence were truly commendable and their proactive approach made the entire process seamless and ensured that we met the stringent regulatory timelines. Their core scientific knowledge, hands-on experience with the pharmaceutical industry and caliber of their work make them a standout choice. It is evident that they take great pride in what they do, and this pride reflects in the exceptional quality of their work. We strongly recommend Consult Lhasa to anyone seeking expert advice on API degradation profile, drug-excipient compatibility, leachables &amp; extractables, potentially mutagenic and non-mutagenic impurities and most importantly the nitrosamine impurities.&#8221;<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2397f38 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2397f38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Muzaffar Khan, Senior General Manager within Regulatory Affairs at Laurus Labs Limited<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-22125ee\" data-id=\"22125ee\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa07a5b elementor-widget elementor-widget-image\" data-id=\"aa07a5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan.png\" class=\"attachment-full size-full wp-image-2764\" alt=\"Muzaffar Khan testimonial image\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan.png 1080w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan-1024x1024.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2023\/12\/Muzaffar-Khan-768x768.png 768w\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"1885\" class=\"elementor elementor-1885 swiper-slide e-loop-item e-loop-item-4206 post-4206 testimonial type-testimonial status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" role=\"group\" aria-roledescription=\"slide\" data-custom-edit-handle=\"1\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7e552b6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7e552b6\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-169dc22\" data-id=\"169dc22\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9839265 elementor-widget elementor-widget-theme-post-content\" data-id=\"9839265\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-content.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p>\u201c<span data-teams=\"true\">We recently had the opportunity to collaborate with Consult Lhasa on the AI\/ limit derivation of a new NDSRI. Given the challenge of limited specific data available for the queried nitrosamine, we sought Consult Lhasa\u2019s expertise to enhance the robustness of our Read-Across approach. Their work is referenced in the latest global regulatory updates on nitrosamines, and this high level of scientific rigor was clearly reflected in their deliverables.<br \/>\nWe sincerely thank the team for their deep scientific knowledge, timely efforts, and outstanding support.<br \/>\nWe highly recommend Consult Lhasa and look forward to another productive collaboration in the future.<\/span>\u201d<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2397f38 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2397f38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Eleni Politi, Chemistry, Manufacturing and Controls\/Safety Toxicologist at Rontis Hellas<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-22125ee\" data-id=\"22125ee\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa07a5b elementor-widget elementor-widget-image\" data-id=\"aa07a5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2025\/09\/Untitled-design-2-e1756990697238.png\" class=\"attachment-full size-full wp-image-4208\" alt=\"Eleni Politi, MSc\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"1885\" class=\"elementor elementor-1885 swiper-slide e-loop-item e-loop-item-5030 post-5030 testimonial type-testimonial status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" role=\"group\" aria-roledescription=\"slide\" data-custom-edit-handle=\"1\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7e552b6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7e552b6\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-169dc22\" data-id=\"169dc22\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9839265 elementor-widget elementor-widget-theme-post-content\" data-id=\"9839265\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-content.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p>\u201c&#8217;<em>Working with Consult Lhasa for our ICH M7 assessments has been a very positive experience for us.\u00a0 It has been really impactful for us to confidently rely on the scientists at Consult Lhasa to deliver high quality expert assessments.\u00a0 You have a great team!<\/em>\u201d<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2397f38 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2397f38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Krista Dobo, Senior Director Toxicology Impurity Risk Management at Pfizer<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-22125ee\" data-id=\"22125ee\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa07a5b elementor-widget elementor-widget-image\" data-id=\"aa07a5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/08\/Untitled-design-14.png\" class=\"attachment-full size-full wp-image-5031\" alt=\"\" srcset=\"https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/08\/Untitled-design-14.png 1024w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/08\/Untitled-design-14-300x300.png 300w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/08\/Untitled-design-14-150x150.png 150w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/08\/Untitled-design-14-768x768.png 768w, https:\/\/www.consultlhasa.com\/wp-content\/uploads\/2026\/08\/Untitled-design-14-12x12.png 12w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-swiper-button 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class=\"elementor-button-text\">View more testimonials<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-03dafe7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"03dafe7\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-98037df\" data-id=\"98037df\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-137d511 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"137d511\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"Layer_2\" viewBox=\"0 0 104.31 65.2\"><defs><style>.cls-1{fill:#11381f;}<\/style><\/defs><g id=\"Layer_1-2\"><path class=\"cls-1\" 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elementor-col-100 elementor-top-column elementor-element elementor-element-ac885e3\" data-id=\"ac885e3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3310129 elementor-widget elementor-widget-heading\" data-id=\"3310129\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Get in touch\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52cd6d9 elementor-widget elementor-widget-text-editor\" data-id=\"52cd6d9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>If you are interested in discovering how Consult Lhasa could improve your non-mutagenic impurities risk assessments, get in touch.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c8d12d elementor-align-center elementor-widget elementor-widget-button\" data-id=\"0c8d12d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.consultlhasa.com\/contact-us\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Consult an expert<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Non-mutagenic impurities Supporting the assessment and control of your non-mutagenic impurities and contaminants Get in touch Assessment and control of 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