{"id":26,"date":"2020-01-22T09:52:57","date_gmt":"2020-01-22T09:52:57","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?page_id=26"},"modified":"2025-11-04T14:21:31","modified_gmt":"2025-11-04T14:21:31","slug":"regulatory-and-quality-proficiency","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/regulatory-and-quality-proficiency\/","title":{"rendered":"Regulatory Support"},"content":{"rendered":"\n<h4 class=\"wp-block-heading\" id=\"h-almac-diagnostic-services-regulatory-affairs-team-has-extensive-experience-in-engaging-with-global-regulatory-authorities-throughout-the-ivd-and-companion-diagnostic-cdx-lifecycle-drawing-on-an-in-depth-knowledge-of-molecular-diagnostic-product-development-nbsp\">Almac Diagnostic Services regulatory affairs team has extensive experience in engaging with global regulatory authorities throughout the IVD and companion diagnostic (CDx) lifecycle, drawing on an in-depth knowledge of molecular diagnostic product development.&nbsp;<\/h4>\n\n\n\n<p>We provide invaluable support to our clients from the investigational clinical trial phase through to the post-market phase, resulting in successful regulatory submissions and ultimately a fast and efficient path to market.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-medium-font-size\" id=\"h-stand-alone-consultancy-or-product-development-service\"><strong>Stand-alone Consultancy or Product Development Service:<\/strong><\/h3>\n\n\n\n<p>Our regulatory services can be provided either as a stand-alone consultancy service or as part of an over-arching product development service. Engage with us early to determine how we can best support your needs.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-medium-font-size\" id=\"h-our-full-range-of-regulatory-support-solutions-include\"><strong>Our full range of regulatory support solutions include:<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Global regulatory strategies for CDx development<\/li>\n\n\n\n<li>IVD\/CDx Q-submissions (pre-submissions, study risk determinations, informational meetings)<\/li>\n\n\n\n<li>FDA IDE &amp; PMA submissions<\/li>\n\n\n\n<li>IVDR compliant technical documentation<\/li>\n\n\n\n<li>EU Notified Body engagement&nbsp;<\/li>\n\n\n\n<li>EU device &amp; performance evaluation registration\/application<\/li>\n\n\n\n<li>Device classification assistance<\/li>\n\n\n\n<li>Performance evaluation planning &amp; reporting (scientific, analytical and clinical, including bridging studies)<\/li>\n\n\n\n<li>3rd party investigator\/site selection, initiation, monitoring and close-out (inclusive of sites within China)<\/li>\n\n\n\n<li>Benefit-risk analysis<\/li>\n\n\n\n<li>Change control and associated risk analysis<\/li>\n\n\n\n<li>Regulatory submissions<\/li>\n\n\n\n<li>Regulatory agency liaison (including supporting our client\u2019s FDA CDER\/IND engagements)<\/li>\n\n\n\n<li>Medical device reporting<\/li>\n\n\n\n<li>Post-market surveillance &amp; support (e.g. PMA supplements)<\/li>\n<\/ul>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-medium-font-size\" id=\"h-almac-provide-regulatory-support-services-to-support-the-entire-cdx-lifecycle\"><strong>Almac provide Regulatory Support Services to support the entire CDx lifecycle<\/strong><\/h3>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"955\" height=\"916\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/Regulatory-Support-diagram.jpg\" alt=\"\" class=\"wp-image-2842 lazyload\" data-srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/Regulatory-Support-diagram.jpg 955w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/Regulatory-Support-diagram-300x288.jpg 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/Regulatory-Support-diagram-768x737.jpg 768w\" data-sizes=\"(max-width: 955px) 100vw, 955px\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 955px; --smush-placeholder-aspect-ratio: 955\/916;\" \/><noscript><img decoding=\"async\" width=\"955\" height=\"916\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/Regulatory-Support-diagram.jpg\" alt=\"\" class=\"wp-image-2842\" srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/Regulatory-Support-diagram.jpg 955w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/Regulatory-Support-diagram-300x288.jpg 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/Regulatory-Support-diagram-768x737.jpg 768w\" sizes=\"(max-width: 955px) 100vw, 955px\" \/><\/noscript><\/figure>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-medium-font-size\" id=\"h-ivdr-amp-almac-as-a-health-institution\"><strong>IVDR &amp; Almac as a Health Institution<\/strong><\/h3>\n\n\n\n<p>Almac Diagnostic Services UK laboratory in Craigavon, Northern Ireland meets the definition of a Health Institution in accordance with IVDR (confirmed by the UK Medicines and Healthcare products Regulatory Agency (MHRA)) and meets all IVDR Article 5(5) requirements.<\/p>\n\n\n\n<a class=\"c-btn c-btn-primary c-btn--red\" style=\"color: white !important;\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/eu-ivdr-support-health-institution\/\">Find out more<\/a>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Almac Diagnostic Services regulatory affairs team has extensive experience in engaging with global regulatory authorities throughout the IVD and companion diagnostic (CDx) lifecycle, drawing on an in-depth knowledge of molecular diagnostic product development.&nbsp; We provide invaluable support to our clients from the investigational clinical trial phase through to the post-market phase, resulting in successful regulatory [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":28,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-page-wrapper.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-26","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Regulatory Support - Diagnostic Services<\/title>\n<meta name=\"description\" content=\"Almac Diagnostic Services\u2019 quality accreditations demonstrate that we meet the highest standards of quality and safety, providing complete confidence to our clients.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/regulatory-and-quality-proficiency\/\" \/>\n<meta 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