{"id":4305,"date":"2025-12-03T14:22:47","date_gmt":"2025-12-03T14:22:47","guid":{"rendered":"https:\/\/www.consultlhasa.com\/?page_id=4305"},"modified":"2025-12-05T12:58:06","modified_gmt":"2025-12-05T12:58:06","slug":"extractables-and-leachables","status":"publish","type":"page","link":"https:\/\/www.consultlhasa.com\/es\/our-services\/extractables-and-leachables\/","title":{"rendered":"Extra\u00edbles y lixiviables"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4305\" class=\"elementor elementor-4305\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5528f4e elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"5528f4e\" 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-6f7476e\" data-id=\"6f7476e\" 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-c5a257f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c5a257f\" 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-8f75e04\" data-id=\"8f75e04\" 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-c41ecd1\" data-id=\"c41ecd1\" 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-4e2d6e0 elementor-widget elementor-widget-heading\" data-id=\"4e2d6e0\" 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\">Extractables and Leachables<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-541fb5b elementor-widget elementor-widget-heading\" data-id=\"541fb5b\" 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 your complete extractables and leachables (E&amp;L) risk assessment profile<\/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-f7427bd\" data-id=\"f7427bd\" 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-3040532 elementor-widget elementor-widget-spacer\" data-id=\"3040532\" 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-a999fcd elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a999fcd\" 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-c60768b elementor-widget elementor-widget-spacer\" data-id=\"c60768b\" 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-b67ad5b elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"b67ad5b\" 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-b9847d3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b9847d3\" data-element_type=\"section\" data-e-type=\"section\" id=\"contact\" 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-a6f9df1\" data-id=\"a6f9df1\" 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-5346b69 elementor-widget elementor-widget-heading\" data-id=\"5346b69\" 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\">E&amp;L risk assessment<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91a01ec elementor-widget elementor-widget-text-editor\" data-id=\"91a01ec\" 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>Due to rapid global advances in materials engineering, device innovations and new manufacturing models, determining chemical migration risk from packaging, processing equipment, or container-closure systems has become a key focus.<\/p><p>Leachables, in particular, can pose various safety risk concerns to patient health, ranging from mutagenicity to general toxicity. With the recently released draft ICH Q3E guideline and regional justifications are only increasing.<\/p><p>To protect patient safety, regulatory bodies require assessments to demonstrate that potential extractable and leachable impurities are identified, assessed, and controlled. This helps ensure that patients can use their medicines safely, without undue risk from packaging-related impurities.<\/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-179c1da\" data-id=\"179c1da\" 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-5d50848 elementor-widget elementor-widget-global elementor-global-2396 elementor-widget-html\" data-id=\"5d50848\" 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-3fa7b29 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3fa7b29\" 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-e4d1e0f\" data-id=\"e4d1e0f\" 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-8491eab elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"8491eab\" 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-a9aa47a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a9aa47a\" 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-0a1c36b\" data-id=\"0a1c36b\" 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-7a80ddb elementor-widget elementor-widget-spacer\" data-id=\"7a80ddb\" 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-6a573a3\" data-id=\"6a573a3\" 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-918d210 elementor-widget elementor-widget-heading\" data-id=\"918d210\" 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-91ad5ad elementor-widget elementor-widget-text-editor\" data-id=\"91ad5ad\" 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 provides expert extractable and leachable (E&amp;L) risk assessments, using \u00a0Lhasa Limited science, that can be recognised and trusted by industry and regulatory authorities.<\/p><p>Lhasa Limited has been collaborating with industry and regulatory working groups to drive E&amp;L risk assessment science in line with the latest draft ICH Q3E guideline.<\/p><p>If you need assistance with your complete E&amp;Ls 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-fc4a923 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fc4a923\" 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-9b8dfc2\" data-id=\"9b8dfc2\" 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-7b71463 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"7b71463\" 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-d08fe2b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d08fe2b\" 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-d7188fe\" data-id=\"d7188fe\" 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-6edbcad elementor-widget elementor-widget-heading\" data-id=\"6edbcad\" 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 assess\n<br>Extractables and Leachables?<\/h2>\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-675f8d7 elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"675f8d7\" 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-e700dcf\" data-id=\"e700dcf\" 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-b9fd9e0 elementor-widget elementor-widget-jet-accordion\" data-id=\"b9fd9e0\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"nitrosamine-services\" 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-1951\" class=\"jet-toggle__control elementor-menu-anchor\" data-toggle=\"1\" role=\"button\" tabindex=\"0\" aria-controls=\"jet-toggle-content-1951\" 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\">Risk of Extractables and Leachables<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div id=\"jet-toggle-content-1951\" 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 \/>Could leachables be present in your drug product?<br \/><\/strong>Predicting leachables starts with a theoretical understanding of extractables. We can review your packaging and manufacturing processes to identify potential risks and guide any further experimental evaluation needed. Our approach reflects current best practice and is in compliance with the draft ICH Q3E guideline.<\/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-1952\" class=\"jet-toggle__control elementor-menu-anchor\" data-toggle=\"2\" role=\"button\" tabindex=\"0\" aria-controls=\"jet-toggle-content-1952\" 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\">Safety assessment of Extractables and Leachables<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div id=\"jet-toggle-content-1952\" 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 \/><\/strong><b>Do you need help defining an acceptable exposure level for your leachable?<\/b><b><br \/><\/b>The draft ICH Q3E guideline introduces a structured approach for applying safety thresholds and deriving acceptable exposure levels for leachables, including using the point of departure (POD) to derive a permitted daily exposure (PDE) for systemic toxicity, or an acceptable intake (AI) where mutagenicity is a concern.<br \/>We assess your leachable impurity using the latest guidance and recommend a suitable acceptable exposure level strategy.<\/p><p><strong><br \/>Do you need help evaluating experimental data for your identified leachable?<br \/><\/strong>Where relevant data exists, the robustness of the data needs to be evaluated before it is used in an acceptable exposure level calculation.<br \/>We evaluate the quality of available toxicology data to determine whether it can underpin a safety assessment, and identify any gaps that may require additional supporting evidence.<\/p><p><strong><br \/>Is there a suitable read-across surrogate for your leachable impurity?<br \/><\/strong>When direct toxicological data are limited, the draft ICH Q3E guideline supports the use of scientifically justified read-across.<br \/>We identify potential structural or mechanistic analogues, evaluate their relevance, and determine whether a read-across surrogate can be used to derive a PDE. Our experts provide a clear justification based on multiple toxicokinetic and toxicodynamic factors. We will provide an expert justification for analogue selection and associated acceptable exposure limit.<\/p><p><strong><br \/>What if there is no suitable analogue?<br \/><\/strong>If there is no suitable analogue for your leachable impurity and the draft ICH Q3E guidance published limits are unachievable, we can help you to decide on your next steps.<br \/>We will review the weight of evidence (WoE) and suggest any additional data that may support the use of a WoE approach.<\/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<div class=\"elementor-element elementor-element-746f373 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"746f373\" 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<div class=\"elementor-element elementor-element-49b9179 elementor-widget elementor-widget-heading\" data-id=\"49b9179\" 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-ca212ec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ca212ec\" 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-33 elementor-inner-column elementor-element elementor-element-1764737 elementor-hidden-tablet_extra elementor-hidden-tablet elementor-hidden-mobile\" data-id=\"1764737\" 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-0517177\" data-id=\"0517177\" 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-bc569b2 elementor-flip-box--effect-flip elementor-flip-box--direction-up elementor-widget elementor-widget-flip-box\" data-id=\"bc569b2\" 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-q3e.svg\" class=\"attachment-full size-full wp-image-677\" 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\tDraft ICH Q3E guideline\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 evaluating extractables and leachables that may be present in a drug product due to packaging, processing or container closure systems. The draft ICH Q3E guideline provides a structured approach for identifying leachables, evaluating their toxicological risk, and establishing appropriate safety thresholds.\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-33 elementor-inner-column elementor-element elementor-element-d6d6f1e elementor-hidden-tablet_extra elementor-hidden-tablet elementor-hidden-mobile\" data-id=\"d6d6f1e\" 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\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-3d13456 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3d13456\" 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-35bc167\" data-id=\"35bc167\" 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-10a1ca3 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"10a1ca3\" 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-b2d7dd9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b2d7dd9\" 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-d3250a1\" data-id=\"d3250a1\" 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-1348452 elementor-arrows-position-inside elementor-widget elementor-widget-global elementor-global-2143 elementor-widget-loop-carousel\" data-id=\"1348452\" 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 fetchpriority=\"high\" 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 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>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-prev\" role=\"button\" tabindex=\"0\" aria-label=\"Anterior\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-chevron-left\"><\/i>\t\t\t<\/div>\n\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-next\" role=\"button\" tabindex=\"0\" aria-label=\"Siguiente\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-chevron-right\"><\/i>\t\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-2b0a4b0 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"2b0a4b0\" 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\/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-c80cfc7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c80cfc7\" 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-151907f\" data-id=\"151907f\" 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-d772461 elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"d772461\" 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-e7445e6 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"e7445e6\" 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-a600d08\" data-id=\"a600d08\" 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-05d3608 elementor-widget elementor-widget-heading\" data-id=\"05d3608\" 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-306df92 elementor-widget elementor-widget-text-editor\" data-id=\"306df92\" 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 nitrosamine 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-ae6ff53 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"ae6ff53\" 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>Extractables and Leachables Supporting your complete extractables and leachables (E&amp;L) risk assessment profile Get in touch E&amp;L risk assessment Due [&hellip;]<\/p>\n","protected":false},"author":6,"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":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","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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