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Regulatory Acceptance | PathoQuest

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class="et_parallax_bg_wrap"><span class="et_parallax_bg" style="background-image: url(https://pathoquest.com/wp-content/uploads/2024/07/Regulatory-banner.png);" ></span></span> <div class="et_pb_row et_pb_row_0 et_pb_equal_columns et_pb_gutters2"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_0 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_0 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h1 style="text-align: center;">Regulatory</h1></div> </div> </div> </div><div class="et_pb_row et_pb_row_1 et_animated"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_1 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_image et_pb_image_0"> <span class="et_pb_image_wrap "><img decoding="async" src="https://pathoquest.com/wp-content/uploads/2024/03/IDtect_Logo_Banner_home.svg" alt="" title="IDtect_Logo_Banner_home" class="wp-image-1240" /></span> </div> </div> </div> </div><div class="et_pb_section et_pb_section_1 et_pb_with_background et_pb_section_parallax et_section_regular" > <div class="et_pb_row et_pb_row_2 et_pb_equal_columns et_pb_gutters3"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_2 vertical-align et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2 style="text-align: center;">Regulatory acceptance</h2></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_0 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_2 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p style="text-align: center;">Our iDTECT庐 NGS-based assays meet the highest regulatory requirements in biotesting, guaranteeing accuracy, reliability and compliance.</p></div> </div> </div> </div><div class="et_pb_row et_pb_row_3 et_pb_equal_columns et_pb_gutters2"> <div class="et_pb_column et_pb_column_1_3 et_pb_column_3 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_image et_pb_image_1"> <span class="et_pb_image_wrap "><img decoding="async" src="https://pathoquest.com/wp-content/uploads/2024/02/All_Icons.svg" alt="GMP" title="GMP" class="wp-image-1187" /></span> </div><div class="et_pb_module et_pb_text et_pb_text_3 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h3 style="text-align: center;">GMP</h3></div> </div> </div><div class="et_pb_column et_pb_column_1_3 et_pb_column_4 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_image et_pb_image_2"> <span class="et_pb_image_wrap "><img decoding="async" src="https://pathoquest.com/wp-content/uploads/2024/07/Icons_Compliant-ICH-Q5A-Q5B.svg" alt="" title="Icons_Compliant - ICH Q5A &amp; Q5B" class="wp-image-1663" /></span> </div><div class="et_pb_module et_pb_text et_pb_text_4 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h3 style="text-align: center;">Compliant with ICH Q5A &amp; Q5B</h3></div> </div> </div><div class="et_pb_column et_pb_column_1_3 et_pb_column_5 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_image et_pb_image_3"> <span class="et_pb_image_wrap "><img decoding="async" src="https://pathoquest.com/wp-content/uploads/2024/07/Icons_Biometric.svg" alt="" title="Icons_Biologic" class="wp-image-1664" /></span> </div><div class="et_pb_module et_pb_text et_pb_text_5 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h3 style="text-align: center;">Biologics Master Files (FDA)</h3></div> </div> </div> </div><div class="et_pb_row et_pb_row_4 et_pb_equal_columns et_pb_gutters3"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_6 vertical-align et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_divider et_pb_divider_1 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_6 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h3 style="text-align: center;"><span style="color: #ff9900;"><strong>REGULATORY NEWS: Discover the EFPIA Position Paper on NGS for Adventitious Virus Detection (JUNE 2024):</strong> <a href="https://pathoquest.com/new-efpia-position-paper/" target="_blank" rel="noopener"><strong><span style="color: #00ccff;">Click Here</span></strong></a></span></h3> <h4 style="text-align: center;"><span style="color: #000080;">A practical implementation guide providing an industry position for discussion with the Regulatory Authorities.</span></h4></div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_2 et_pb_section_parallax et_pb_with_background et_section_regular" > <span class="et_parallax_bg_wrap"><span class="et_parallax_bg" style="background-image: url(https://pathoquest.com/wp-content/uploads/2023/06/db_Pathoquest.svg);" ></span></span> <div class="et_pb_row et_pb_row_5"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_7 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_7 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2 style="text-align: left;">Regulatory guidance for <span style="color: #ff9900;">viral safety</span></h2></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_2 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div> </div> </div><div class="et_pb_row et_pb_row_6"> <div class="et_pb_column et_pb_column_1_2 et_pb_column_8 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_8 et_pb_text_align_left et_pb_bg_layout_dark"> <div class="et_pb_text_inner"><ul> <li><span style="color: #ffffff;"><strong>Supporting NGS as an alternative to traditional in vivo assays in line with ICHQ5A(R2) and Ph. Eur.</strong></span></li> </ul> <p style="padding-left: 40px;">Our iDTECT庐 NGS assays are validated in accordance with key regulatory guidelines, including ICH Q5A(R2) and the European Pharmacopoeia. These guidelines recognize the advantages of NGS over traditional <em>in vivo</em> assays, emphasizing its superior sensitivity and broad range of detection capabilities.</p> <p style="padding-left: 40px;"><em><span style="color: #00ccff;">ICH Q5A(R2) 3.2.3</span>: NGS is encouraged as a replacement for in vivo assays due to its enhanced detection capabilities and alignment with global objectives to reduce animal testing.</em></p> <p style="padding-left: 40px;"><em><span style="color: #00ccff;">Ph. Eur. 5.2.14</span>: Highlights the ability of NGS to detect previously undetected viral contaminants, thereby identifying gaps in existing testing strategies.</em></p> <p style="padding-left: 40px;"><em><span style="color: #00ccff;">Ph. Eur. 2.6.16</span> and <span style="color: #00ccff;">Ph. Eur. 5.2.3</span> support the use of NGS as an alternative to in vivo and specific NAT or as supplement or alternative to in vitro culture tests for extraneous agents testing in vaccine production.</em></p> <p style="padding-left: 40px;"><em></em></p></div> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_9 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_9 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><ul> <li><span style="color: #ffffff;"><strong>Replacing traditional biotesting methods with NGS for:</strong></span></li> </ul> <p style="padding-left: 40px;"><em>In vivo</em> testing. <span style="color: #ff9900;"><a href="https://pubmed.ncbi.nlm.nih.gov/37468389/" title="https://pubmed.ncbi.nlm.nih.gov/37468389/" style="color: #ff9900;" target="_blank" rel="noopener">Download our publication in Vaccine.</a></span></p> <p style="padding-left: 40px;">Mouse, Rat, and Hamster Antibody Production Tests: <span style="color: #00ccff;">ICH Q5A(R2) 3.2.4</span><strong>.</strong>聽<span style="color: #ff9900;"><a href="https://pathoquest.com/wp-content/uploads/2024/02/20240220_Application-Note_HAP-MAP-RAP-replacement-by-iDTECT_A4.pdf" title="https://pathoquest.com/wp-content/uploads/2024/02/20240220_Application-Note_HAP-MAP-RAP-replacement-by-iDTECT_A4.pdf" style="color: #ff9900;" target="_blank" rel="noopener">Download our application note.</a> </span></p> <p style="padding-left: 40px;"><em>In vitro</em> adventitious virus tests and cell culture infectivity assays: <span style="color: #00ccff;">ICH Q5A(R2) 3.2.2</span>.</p> <p style="padding-left: 40px;">Molecular methods: <span style="color: #00ccff;">ICH Q5A(R2) 3.2.5</span>.</p> <p style="padding-left: 40px;"><span class="OYPEnA text-decoration-none text-strikethrough-none"><span style="color: #00ccff;">Ph. Eur. 2.6.41.</span> (draft, April 2024) </span><span class="OYPEnA text-decoration-none text-strikethrough-none">provides with comprehensive guidance on NGS methodologies for viral extraneous agents detection in biological products, including method design, workflow steps, analysis approaches, routine controls, and validation procedures, with the aim of facilitating</span><span class="OYPEnA text-decoration-none text-strikethrough-none white-space-prewrap"> </span><span class="OYPEnA text-decoration-none text-strikethrough-none">the implementation of NGS-based adventitious virus testing.</span></p></div> </div> </div> </div><div class="et_pb_row et_pb_row_7"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_10 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_divider et_pb_divider_3 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div> </div> </div><div class="et_pb_row et_pb_row_8"> <div class="et_pb_column et_pb_column_1_2 et_pb_column_11 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_10 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2 style="text-align: left;">Regulatory guidance for <span style="color: #ff9900;">genetic characterization</span></h2></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_4 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_12 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_11 et_pb_text_align_left et_pb_bg_layout_dark"> <div class="et_pb_text_inner"><ul> <li><strong><span style="color: #ffffff;">Complying with ICH Q5B and Ph. Eur.</span></strong></li> </ul> <p style="padding-left: 40px;"><span style="color: #00ccff;">ICH Q5B III.A.</span> Expression Construct and Cell Clone: DNA sequencing is required to determine the nucleotide sequence of the coding region of the gene of interest, including associated flanking regions inserted into the vector, and the junctions of insertion.</p> <p style="padding-left: 40px;"><span style="color: #00ccff;">ICH Q5B III.B.</span> Cell Bank System: Allows the use of alternative suitable techniques for the analysis of the expression construct for integration sites and configuration of expression constructs.</p> <p style="padding-left: 40px;"><span style="color: #00ccff;">Ph.Eur. 5.14</span> and <span style="color: #00ccff;">ICHQ5B</span> emphasize the need for precise genetic characterization, including the identity of the transgene, regulatory elements and detection of variations greater than 5%.</p> <p style="padding-left: 40px;">The European Pharmacopoeia Commission has introduced a <span style="color: #00ccff;">new</span> <span style="color: #00ccff;">monograph, Gene Therapy Medicinal Products for Human Use (3186)</span>, replacing the previous chapter, Gene Transfer Medicinal Products (5.14). This update sets clearer requirements for GTMPs, including genetically modified cells and viral vectors. These changes, effective April 2025, mark a significant step toward standardized control of advanced therapies. <span style="color: #ff9900;"><a href="https://www.edqm.eu/en/w/new-european-pharmacopoeia-commission-approach-to-gene-therapy-1" style="color: #ff9900;" target="_blank" rel="noopener">More information.</a></span></p> <p style="padding-left: 40px;"></div> </div> </div> </div><div class="et_pb_row et_pb_row_9"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_13 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_divider et_pb_divider_5 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div> </div> </div><div class="et_pb_row et_pb_row_10"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_14 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_12 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2 style="text-align: left;">Proactive engagement with <span style="color: #ff9900;">regulatory bodies and expert groups</span></h2></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_6 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div> </div> </div><div class="et_pb_row et_pb_row_11"> <div class="et_pb_column et_pb_column_1_2 et_pb_column_15 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_13 et_pb_text_align_left et_pb_bg_layout_dark"> <div class="et_pb_text_inner"><ul> <li><span style="color: #ffffff;"><strong>Registered Biologics Master File at the FDA (Food and Drug Administration) for iDTECT庐 assays</strong></span></li> </ul></div> </div><div class="et_pb_module et_pb_text et_pb_text_14 et_pb_text_align_left et_pb_bg_layout_dark"> <div class="et_pb_text_inner"><ul> <li><span style="color: #ffffff;"><strong>Consultations with regulatory authorities: </strong></span></li> </ul> <p><span style="color: #ffffff;"><strong>ANSM (Agence Nationale de S茅curit茅 du M茅dicament et des produits de sant茅):</strong></span></p> <p style="padding-left: 40px;">ANSM minutes: Substitution of <em>in vitro</em> and <em>in vivo</em> virus testing with PathoQuest Transcriptome assay. <span style="color: #ff9900;"><a href="https://pathoquest.com/wp-content/uploads/2024/07/20221129-cr-csp-securite-et-qualite-des-medicaments-securite-virale-3.pdf" title="https://pathoquest.com/ngs-ansm/" style="color: #ff9900;" target="_blank" rel="noopener">Download the report.</a></span></p> <p><span style="color: #ffffff;"><strong>EMA (European Medicines Agency):</strong></span></p> <p style="padding-left: 40px;">Substitution of <em>in vitro</em> and<em> in vivo</em> virus testing by iDTECT庐 Transcriptome assay (2024 03 24): <span style="color: #ff9900;"><a href="https://pathoquest.com/wp-content/uploads/2024/04/2023-02-23-PathoQuest-Briefing-Meeting-Report-final.pdf" title="https://pathoquest.com/wp-content/uploads/2024/04/2023-02-23-PathoQuest-Briefing-Meeting-Report-final.pdf" style="color: #ff9900;" target="_blank" rel="noopener">Download the report.</a></span></p></div> </div><div class="et_pb_module et_pb_text et_pb_text_15 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p style="padding-left: 80px;"><em>The views expressed in this document are the opinion of the participating members of the Innovation Task Force and the experts, and may not reflect the opinion of the EMA scientific committees.</em></p></div> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_16 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_16 et_pb_text_align_left et_pb_bg_layout_dark"> <div class="et_pb_text_inner"><ul> <li><span style="color: #ffffff;"><strong>Participation in regulatory committees</strong> such as the European Directorate for the Quality of Medicines &amp; HealthCare (EDQM) on cutting-edge research:</span></li> </ul> <p style="padding-left: 40px;">Meeting held in December 2023 with the members of the EDQM Gene Therapy Working Group. The Group consists of the 11 OMCLs (Official Medicines Control Laboratories) and the members are mostly regulators from Europe, one from Canada and an observer from Asia. <span style="color: #ff9900;"><a href="https://pathoquest.com/wp-content/uploads/2024/04/OMCL_23_104-003_rev-PTQ.pdf" title="https://pathoquest.com/wp-content/uploads/2024/04/OMCL_23_104-003_rev-PTQ.pdf" style="color: #ff9900;" target="_blank" rel="noopener">See the agenda.</a></span></p> <p style="padding-left: 40px;"></div> </div><div class="et_pb_module et_pb_text et_pb_text_17 et_pb_text_align_left et_pb_bg_layout_dark"> <div class="et_pb_text_inner"><ul> <li><span style="color: #ffffff;"><strong>Membership in expert groups:</strong></span></li> </ul> <p style="padding-left: 40px;">EFPIA (European Federation of Pharmaceutical Industries and Associations) since 2019.</p> <p style="padding-left: 80px;"><span style="color: #ff9900;"><strong>JUNE 2024</strong></span> Position paper on Next Generation Sequencing (NGS) for adventitious virus detection in biological medicinal products, with key contributions from PathoQuest. <span style="color: #ff9900;"><a href="https://www.efpia.eu/media/t22f5yoz/efpia-ngs-virus-detection-paper_finaljun2024.pdf" title="https://www.efpia.eu/media/t22f5yoz/efpia-ngs-virus-detection-paper_finaljun2024.pdf" style="color: #ff9900;" target="_blank" rel="noopener">Download the position paper.</a></span></p> <p style="padding-left: 40px;">AVDTIG (Advanced Virus Detection Technologies Interest Group) since 2014.</p> <p style="padding-left: 40px;"></div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_3 et_pb_with_background et_pb_section_parallax et_section_regular" > <div class="et_pb_row et_pb_row_12 et_pb_equal_columns et_pb_gutters3"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_17 vertical-align et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_18 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2 style="text-align: center;">Quality</h2></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_7 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_19 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p style="text-align: center;">Quality is at the core of our operations. 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{jQuery('#gform_wrapper_1').removeClass('gform_validation_error');}setTimeout( function() { /* delay the scroll by 50 milliseconds to fix a bug in chrome */ jQuery(document).scrollTop(jQuery('#gform_wrapper_1').offset().top - mt); }, 50 );if(window['gformInitDatepicker']) {gformInitDatepicker();}if(window['gformInitPriceFields']) {gformInitPriceFields();}var current_page = jQuery('#gform_source_page_number_1').val();gformInitSpinner( 1, 'https://pathoquest.com/wp-content/plugins/gravityforms/images/spinner.svg', true );jQuery(document).trigger('gform_page_loaded', [1, current_page]);window['gf_submitting_1'] = false;}else if(!is_redirect){var confirmation_content = jQuery(this).contents().find('.GF_AJAX_POSTBACK').html();if(!confirmation_content){confirmation_content = contents;}jQuery('#gform_wrapper_1').replaceWith(confirmation_content);jQuery(document).scrollTop(jQuery('#gf_1').offset().top - mt);jQuery(document).trigger('gform_confirmation_loaded', [1]);window['gf_submitting_1'] = false;wp.a11y.speak(jQuery('#gform_confirmation_message_1').text());}else{jQuery('#gform_1').append(contents);if(window['gformRedirect']) {gformRedirect();}}jQuery(document).trigger("gform_pre_post_render", [{ formId: "1", currentPage: "current_page", abort: function() { this.preventDefault(); } }]); if (event && event.defaultPrevented) { return; } const gformWrapperDiv = document.getElementById( "gform_wrapper_1" ); if ( gformWrapperDiv ) { const visibilitySpan = document.createElement( "span" ); visibilitySpan.id = "gform_visibility_test_1"; gformWrapperDiv.insertAdjacentElement( "afterend", visibilitySpan ); } const visibilityTestDiv = document.getElementById( "gform_visibility_test_1" ); let postRenderFired = false; function triggerPostRender() { if ( postRenderFired ) { return; } postRenderFired = true; jQuery( document ).trigger( 'gform_post_render', [1, current_page] ); gform.utils.trigger( { event: 'gform/postRender', native: false, data: { formId: 1, currentPage: current_page } } ); if ( visibilityTestDiv ) { visibilityTestDiv.parentNode.removeChild( visibilityTestDiv ); } } function debounce( func, wait, immediate ) { var timeout; return function() { var context = this, args = arguments; var later = function() { timeout = null; if ( !immediate ) func.apply( context, args ); }; var callNow = immediate && !timeout; clearTimeout( timeout ); timeout = setTimeout( later, wait ); if ( callNow ) func.apply( context, args ); }; } const debouncedTriggerPostRender = debounce( function() { triggerPostRender(); }, 200 ); if ( visibilityTestDiv && visibilityTestDiv.offsetParent === null ) { const observer = new MutationObserver( ( mutations ) => { mutations.forEach( ( mutation ) => { if ( mutation.type === 'attributes' && visibilityTestDiv.offsetParent !== null ) { debouncedTriggerPostRender(); observer.disconnect(); } }); }); observer.observe( document.body, { attributes: true, childList: false, subtree: true, attributeFilter: [ 'style', 'class' ], }); } else { triggerPostRender(); } } );} ); /* ]]&gt; */ </script> </section> </div> </div> </div> </div><div class="et_pb_row et_pb_row_16 et_pb_equal_columns et_pb_gutters1"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_24 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_28 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2><span style="color: #ffffff;"><span class="ui-provider bra brb c d e f g h i j k l m n o p q r s t brc brd w x y z ab ac ae af ag ah ai aj ak" dir="ltr">U.S.</span></span></h2></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_10 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_29 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><span class="ui-provider bra brb c d e f g h i j k l m n o p q r s t brc brd w x y z ab ac ae af ag ah ai aj ak" dir="ltr" style="color: #ffffff;"><a rel="noreferrer noopener" title="tel:+14842129360" target="_blank" style="color: #ffffff;">+1 484 212 9360</a></span></p> <p><span style="color: #ffffff;">466 Devon Park Dr<br />Wayne, PA 19087<br />United States</span></p></div> </div><div class="et_pb_module et_pb_text et_pb_text_30 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2><span style="color: #ffffff;"><span class="ui-provider bra brb c d e f g h i j k l m n o p q r s t brc brd w x y z ab ac ae af ag ah ai aj ak" dir="ltr">France</span></span></h2></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_11 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_31 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><span style="color: #ffffff;">+33聽(0)1 70 82 17 90</span></p> <p><span style="color: #ffffff;">Biopark -B芒timent B,<br />11, rue Watt<br />75013 Paris, France</span></p></div> </div><div class="et_pb_module et_pb_text et_pb_text_32 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><strong>How can PathoQuest help?</strong></p></div> </div><div class="et_pb_module et_pb_wpt_gravityform et_pb_wpt_gravityform_1"> <div class="et_pb_module_inner"> <section class='et_pb_module et_pb_wpt_gravityform et_pb_wpt_gravityform_1' data-class='et_pb_module et_pb_wpt_gravityform et_pb_wpt_gravityform_1' id="" data-type='et_pb_wpt_gravityform' data-is-sticky='no'> <div class='gf_browser_gecko gform_wrapper gravity-theme gform-theme--no-framework' data-form-theme='gravity-theme' data-form-index='1' id='gform_wrapper_1' ><form method='post' enctype='multipart/form-data' id='gform_1' action='/regulatory/' data-formid='1' novalidate> <input type='hidden' class='gforms-pum' value='{"closepopup":false,"closedelay":0,"openpopup":false,"openpopup_id":0}' /> <div class='gform-body gform_body'><div id='gform_fields_1' class='gform_fields top_label form_sublabel_above description_above validation_below'><fieldset id="field_1_1" class="gfield gfield--type-name gfield_contains_required field_sublabel_above gfield--no-description field_description_above field_validation_below gfield_visibility_visible" data-js-reload="field_1_1" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >Name<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></legend><div class='ginput_complex ginput_container ginput_container--name no_prefix has_first_name no_middle_name has_last_name no_suffix gf_name_has_2 ginput_container_name gform-grid-row' id='input_1_1'> <span id='input_1_1_3_container' class='name_first gform-grid-col gform-grid-col--size-auto' > <label for='input_1_1_3' class='gform-field-label gform-field-label--type-sub '>First</label> <input type='text' name='input_1.3' id='input_1_1_3' value='' aria-required='true' autocomplete="given-name" /> </span> <span id='input_1_1_6_container' class='name_last gform-grid-col gform-grid-col--size-auto' > <label for='input_1_1_6' class='gform-field-label gform-field-label--type-sub '>Last</label> <input type='text' name='input_1.6' id='input_1_1_6' value='' aria-required='true' autocomplete="family-name" /> </span> </div></fieldset><div id="field_1_2" class="gfield gfield--type-email gfield_contains_required field_sublabel_above gfield--no-description field_description_above field_validation_below gfield_visibility_visible" data-js-reload="field_1_2" ><label class='gfield_label gform-field-label' for='input_1_2'>Email<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></label><div class='ginput_container ginput_container_email'> <input name='input_2' id='input_1_2' type='email' value='' class='large' aria-required="true" aria-invalid="false" /> </div></div><div id="field_1_4" class="gfield gfield--type-text gfield--width-full gfield_contains_required field_sublabel_above gfield--no-description field_description_above field_validation_below gfield_visibility_visible" data-js-reload="field_1_4" ><label class='gfield_label gform-field-label' for='input_1_4'>Company<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></label><div class='ginput_container ginput_container_text'><input name='input_4' id='input_1_4' type='text' value='' class='large' aria-required="true" aria-invalid="false" /> </div></div><div id="field_1_8" class="gfield gfield--type-text gfield--width-full gfield_contains_required field_sublabel_above gfield--no-description field_description_above field_validation_below gfield_visibility_visible" data-js-reload="field_1_8" ><label class='gfield_label gform-field-label' for='input_1_8'>Country<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></label><div class='ginput_container ginput_container_text'><input name='input_8' id='input_1_8' type='text' value='' class='large' aria-required="true" aria-invalid="false" /> </div></div><div id="field_1_3" class="gfield gfield--type-textarea gfield_contains_required field_sublabel_above gfield--no-description field_description_above field_validation_below gfield_visibility_visible" data-js-reload="field_1_3" ><label class='gfield_label gform-field-label' for='input_1_3'>Tell us more about your needs and projects<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></label><div class='ginput_container ginput_container_textarea'><textarea name='input_3' id='input_1_3' class='textarea medium' maxlength='600' aria-required="true" aria-invalid="false" rows='10' cols='50'></textarea></div></div><fieldset id="field_1_6" class="gfield gfield--type-consent gfield--type-choice gfield--input-type-consent gfield_contains_required field_sublabel_above gfield--no-description field_description_above field_validation_below gfield_visibility_visible" data-js-reload="field_1_6" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >By submitting this form, PathoQuest will use the personal data you provide to handle your request. Read our Privacy Notice for more information.<span class="gfield_required"><span class="gfield_required gfield_required_text">(Required)</span></span></legend><div class='ginput_container ginput_container_consent'><input name='input_6.1' id='input_1_6_1' type='checkbox' value='1' aria-required="true" aria-invalid="false" /> <label class="gform-field-label gform-field-label--type-inline gfield_consent_label" for='input_1_6_1' >I agree to the privacy policy.</label><input type='hidden' name='input_6.2' value='I agree to the privacy policy.' class='gform_hidden' /><input type='hidden' name='input_6.3' value='2' class='gform_hidden' /></div></fieldset><div id="field_1_9" class="gfield gfield--type-honeypot gform_validation_container field_sublabel_above gfield--has-description field_description_above field_validation_below gfield_visibility_visible" data-js-reload="field_1_9" ><label class='gfield_label gform-field-label' for='input_1_9'>Name</label><div class='gfield_description' id='gfield_description_1_9'>This field is for validation purposes and should be left unchanged.</div><div class='ginput_container'><input name='input_9' id='input_1_9' type='text' value='' autocomplete='new-password'/></div></div></div></div> <div class='gform_footer top_label'> <input type='submit' id='gform_submit_button_1' class='gform_button button et_pb_button' value='Submit' onclick='if(window["gf_submitting_1"]){return false;} if( !jQuery("#gform_1")[0].checkValidity || jQuery("#gform_1")[0].checkValidity()){window["gf_submitting_1"]=true;} ' onkeypress='if( event.keyCode == 13 ){ if(window["gf_submitting_1"]){return false;} if( !jQuery("#gform_1")[0].checkValidity || jQuery("#gform_1")[0].checkValidity()){window["gf_submitting_1"]=true;} jQuery("#gform_1").trigger("submit",[true]); }' /> <input type='hidden' class='gform_hidden' name='is_submit_1' value='1' /> <input type='hidden' class='gform_hidden' name='gform_submit' value='1' /> <input type='hidden' class='gform_hidden' name='gform_unique_id' value='' /> <input type='hidden' class='gform_hidden' name='state_1' value='WyJ7XCI2LjFcIjpcImI5ZDIyMDQ1YjdjYTViMTQ1NzYwODc1NmY3ZjRlMGYyXCIsXCI2LjJcIjpcIjJhYTFhOGQ0NDNiMTFjY2YzOGNlNTAyNmNlZmQ4ZWUxXCIsXCI2LjNcIjpcIjVlM2YzZThhYjhlOWZjZDU4YzVlNTc0ZmM4NTM0OWVmXCJ9IiwiYTc2ZjZhMzE2MTIzZTZjZThjZGQyOTM2ZWFmNGUwYzciXQ==' /> <input type='hidden' class='gform_hidden' name='gform_target_page_number_1' id='gform_target_page_number_1' value='0' /> <input type='hidden' class='gform_hidden' name='gform_source_page_number_1' id='gform_source_page_number_1' value='1' /> <input type='hidden' name='gform_field_values' value='' /> </div> <input type="hidden" id="ct_checkjs_4c56ff4ce4aaf9573aa5dff913df997a" name="ct_checkjs" value="0" /><script >setTimeout(function(){var ct_input_name = "ct_checkjs_4c56ff4ce4aaf9573aa5dff913df997a";if (document.getElementById(ct_input_name) !== null) {var ct_input_value = document.getElementById(ct_input_name).value;document.getElementById(ct_input_name).value = document.getElementById(ct_input_name).value.replace(ct_input_value, '2085491878');}}, 1000);</script><label class="apbct_special_field" id="apbct_label_id17255" for="apbct__email_id__gravity_form_17255">17255</label><input id="apbct__email_id__gravity_form_17255" class="apbct_special_field apbct__email_id__gravity_form" autocomplete="off" name="apbct__email_id__gravity_form_17255" type="text" value="17255" size="30" apbct_event_id="17255" maxlength="200" /><input id="apbct_event_id" class="apbct_special_field" name="apbct_event_id" type="hidden" value="17255" /></form> </div><script type="text/javascript"> /* <![CDATA[ */ gform.initializeOnLoaded( function() {gformInitSpinner( 1, 'https://pathoquest.com/wp-content/plugins/gravityforms/images/spinner.svg', true );jQuery('#gform_ajax_frame_1').on('load',function(){var contents = jQuery(this).contents().find('*').html();var is_postback = contents.indexOf('GF_AJAX_POSTBACK') >= 0;if(!is_postback){return;}var form_content = jQuery(this).contents().find('#gform_wrapper_1');var is_confirmation = jQuery(this).contents().find('#gform_confirmation_wrapper_1').length > 0;var is_redirect = contents.indexOf('gformRedirect(){') >= 0;var is_form = form_content.length > 0 && ! is_redirect && ! is_confirmation;var mt = parseInt(jQuery('html').css('margin-top'), 10) + parseInt(jQuery('body').css('margin-top'), 10) + 100;if(is_form){jQuery('#gform_wrapper_1').html(form_content.html());if(form_content.hasClass('gform_validation_error')){jQuery('#gform_wrapper_1').addClass('gform_validation_error');} else {jQuery('#gform_wrapper_1').removeClass('gform_validation_error');}setTimeout( function() { /* delay the scroll by 50 milliseconds to fix a bug in chrome */ }, 50 );if(window['gformInitDatepicker']) {gformInitDatepicker();}if(window['gformInitPriceFields']) {gformInitPriceFields();}var current_page = jQuery('#gform_source_page_number_1').val();gformInitSpinner( 1, 'https://pathoquest.com/wp-content/plugins/gravityforms/images/spinner.svg', true );jQuery(document).trigger('gform_page_loaded', [1, current_page]);window['gf_submitting_1'] = false;}else if(!is_redirect){var confirmation_content = jQuery(this).contents().find('.GF_AJAX_POSTBACK').html();if(!confirmation_content){confirmation_content = contents;}jQuery('#gform_wrapper_1').replaceWith(confirmation_content);jQuery(document).trigger('gform_confirmation_loaded', [1]);window['gf_submitting_1'] = false;wp.a11y.speak(jQuery('#gform_confirmation_message_1').text());}else{jQuery('#gform_1').append(contents);if(window['gformRedirect']) {gformRedirect();}}jQuery(document).trigger("gform_pre_post_render", [{ formId: "1", currentPage: "current_page", abort: function() { this.preventDefault(); } }]); if (event && event.defaultPrevented) { return; } const gformWrapperDiv = document.getElementById( "gform_wrapper_1" ); if ( gformWrapperDiv ) { const visibilitySpan = document.createElement( "span" ); visibilitySpan.id = "gform_visibility_test_1"; gformWrapperDiv.insertAdjacentElement( "afterend", visibilitySpan ); } const visibilityTestDiv = document.getElementById( "gform_visibility_test_1" ); let postRenderFired = false; function triggerPostRender() { if ( postRenderFired ) { return; } postRenderFired = true; jQuery( document ).trigger( 'gform_post_render', [1, current_page] ); gform.utils.trigger( { event: 'gform/postRender', native: false, data: { formId: 1, currentPage: current_page } } ); if ( visibilityTestDiv ) { visibilityTestDiv.parentNode.removeChild( visibilityTestDiv ); } } function debounce( func, wait, immediate ) { var timeout; return function() { var context = this, args = arguments; var later = function() { timeout = null; if ( !immediate ) func.apply( context, args ); 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data-form-theme='gravity-theme' data-form-index='0' id='gform_wrapper_10' > <div class='gform_heading'> <h2 class="gform_title">Analytical Methods Validation Head contact form</h2> <p class='gform_description'></p> </div><form method='post' enctype='multipart/form-data' id='gform_10' action='/regulatory/' data-formid='10' novalidate> <input type='hidden' class='gforms-pum' value='{"closepopup":false,"closedelay":0,"openpopup":false,"openpopup_id":0}' /> <div class='gform-body gform_body'><div id='gform_fields_10' class='gform_fields top_label form_sublabel_above description_above validation_below'><fieldset id="field_10_1" class="gfield gfield--type-name gfield--input-type-name gfield_contains_required field_sublabel_above gfield--no-description field_description_above field_validation_below gfield_visibility_visible" data-js-reload="field_10_1" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >Name<span class="gfield_required"><span class="gfield_required 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