{"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":"2024-11-19T17:20:38","modified_gmt":"2024-11-19T17:20:38","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-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\tIf 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. \n\nAdditionally, the potential for cross-contamination in shared API manufacturing facilities must be evaluated based on the risk posed by identified cross contaminants. \n\nRegulatory guidelines require careful evaluation of impurity thresholds to demonstrate that exposure is within acceptable limits and will be safe for human exposure.\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-8615198\" data-id=\"8615198\" 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-e2f182e elementor-widget elementor-widget-global elementor-global-2396 elementor-widget-html\" data-id=\"e2f182e\" 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=\"jet-toggle-control-1901\" 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\">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 \/><p><strong><br \/>Do you need help establishing safe limits for your non-genotoxic impurities (NGIs)?<br \/><\/strong>When a non-genotoxic impurity (NGI) is present above the qualification threshold, an impurity qualification becomes necessary. We can provide a weight of evidence assessment to determine a safe limit for your NGI.<\/p><\/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=\"jet-toggle-control-1902\" 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 \/><p><strong><br \/>Does your process involve a residual solvent not included in ICH Q3C?<br \/><\/strong>If a solvent is not included within the ICH Q3C guidelines, an independent calculation is required to determine an acceptable intake. If relevant and robust data exists, we can perform a permitted daily exposure (PDE) risk assessment to establish an acceptable limit for your residual solvent.<\/p><p><strong><br \/>What if there is insufficient data for your solvent, not included in ICH Q3C?<br \/><\/strong>In cases where high-quality data for your residual solvent is unavailable, the correct analogue &#8211; or class of analogues &#8211; needs to be identified. Where possible, we will provide appropriate read-across analogues and utilise the anologue\/s to establish an acceptable intake (AI) for your residual solvent.<\/p><\/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=\"jet-toggle-control-1903\" 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 \/><p><strong><br \/>Do you need help evaluating the level of elemental impurities in your final drug product?<br \/><\/strong>Elemental impurities (EIs) can originate from several sources and need to be controlled to a safe limit. It is important to evaluate each source to understand its contribution to overall EI levels in the final drug product. We can help you to assess the risk of EIs in your final drug product, relative to the permitted daily exposure (PDE), in line with the ICH Q3D guidance. If necessary, based on the risk assessment outcome, we can propose a control strategy.<\/p><\/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=\"jet-toggle-control-1904\" 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 \/><p>\u00a0<\/p><p><strong>Do you need support defining health based exposure limits?<\/strong><\/p><p>When multiple medicinal products are manufactured in a shared facility, the risk of cross-contamination should be evaluated. We can provide a structured scientific evaluation of pharmacological and toxicological data to define a health based exposure limit for your product, considering the other products manufactured within the facility. The outcome will be a threshold value e.g. permitted daily exposure (PDE) or threshold of toxicological concern (TTC) .<\/p><\/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\" 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.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\" 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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\/testimonials\">\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\">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 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class=\"elementor-column 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 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2888,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"content-type":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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