{"id":566840,"date":"2022-07-12T06:36:06","date_gmt":"2022-07-12T06:36:06","guid":{"rendered":"https:\/\/www.capgemini.com\/?page_id=646584"},"modified":"2025-04-03T07:48:27","modified_gmt":"2025-04-03T11:48:27","slug":"regulatory-affairs-compliance-and-quality","status":"publish","type":"page","link":"https:\/\/www.capgemini.com\/ca-en\/solutions\/regulatory-affairs-compliance-and-quality\/","title":{"rendered":"Regulatory Affairs, Compliance and Quality"},"content":{"rendered":"\n<header class=\"wp-block-cg-blocks-hero-reusable header heroReusable  \"><div class=\"header-bgs\"><picture><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg?w=2880&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg?w=2880&amp;quality=70 2x\" media=\"(min-width: 1500px)\"\/><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg?w=1440&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg?w=2880&amp;quality=70 2x\" media=\"(min-width: 992px)\"\/><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg?w=1024&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg?w=1024&amp;quality=70 2x\" media=\"(min-width: 768px)\"\/><source srcset=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg?w=768&amp;quality=70 1x, https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg?w=768&amp;quality=70 2x\" media=\"(min-width: 0)\"\/><img decoding=\"async\" src=\"https:\/\/www.capgemini.com\/wp-content\/uploads\/2022\/04\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg\" class=\"header-img header-img-d\" alt=\"\" style=\"object-fit:cover;object-position:49% 72%\" loading=\"eager\"\/><\/picture><\/div><div class=\"heroPictureCardHeaderShape\"><\/div><div class=\"container\"><div class=\"row\"><div class=\"col-md-12\"><div class=\"box\"><div class=\"boxTagWrapper\"><div class=\"tagInfo\"><div><span class=\"box-tag\">Solution<\/span><\/div><\/div><\/div><div class=\"box-title\"><h1 data-maxlength=\"34\">Regulatory affairs, compliance and quality <\/h1><\/div><div class=\"inner-row-insight download-btn\"><\/div><\/div><\/div><\/div><\/div><\/header>\n\n\n\n<section class=\"wp-block-cg-blocks-intro-para undefined section section--intro\"><div class=\"intro-para\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-md-1\"><nav class=\"article-social\"><ul class=\"social-nav\"><li class=\"ip-order-fb\"><a href=\"https:\/\/www.facebook.com\/sharer\/sharer.php?u=https:\/\/www.capgemini.com\/ca-en\/solutions\/regulatory-affairs-compliance-and-quality\/\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"opens in a new window\"><i aria-hidden=\"true\" class=\"icon-fb\"><\/i><span class=\"sr-only\">Facebook<\/span><\/a><\/li><li class=\"ip-order-li\"><a href=\"https:\/\/www.linkedin.com\/sharing\/share-offsite\/?url=https:\/\/www.capgemini.com\/ca-en\/solutions\/regulatory-affairs-compliance-and-quality\/\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"opens in a new window\"><i aria-hidden=\"true\" class=\"icon-li\"><\/i><span class=\"sr-only\">Linkedin<\/span><\/a><\/li><\/ul><\/nav><\/div><div class=\"col-12 col-md-11 col-lg-10\"><h2 class=\"intro-para-title\">Across the world regulations are growing more complex, but solutions are evolving even faster. Learn how our intelligent regulatory, compliance and quality services can help you cut compliance costs while assuring the highest standards of safety and quality.<\/h2><\/div><\/div><\/div><\/div><\/section>\n\n\n\n<section class=\"wp-block-cg-blocks-group undefined section section--article-content\"><div class=\"article-main-content\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-md-11 col-lg-10 offset-md-1 offset-lg-1\"><div class=\"article-text article-quote-text\">\n<h2 class=\"wp-block-heading\" id=\"h-how-we-can-support-you\">How we can support you<\/h2>\n\n\n\n<p>The scale of regulatory compliance in life sciences today is daunting and it requires a partner with both regulatory compliance expertise and deep industry knowledge.<\/p>\n\n\n\n<p>We are that partner. We support clients with regulatory strategy, regulatory documentation, audits, gap analyses and remediation activities and QMS optimization, managed services and operational QA\/RA support at scale.<\/p>\n\n\n\n<p>Our services come from three angles:&nbsp;<\/p>\n\n\n\n<p><strong>RCQ Consulting<\/strong><\/p>\n\n\n\n<p>Capgemini brings best-in-class consulting services to optimize your core business processes. We work with you from diagnosis to implementation to bring clarity to simplify and speed up compliance with international Health authorities (FDA, EMA) and national authorities on quality systems, quality products and regulatory (GxP, CFR, ICH, ISO).<\/p>\n\n\n\n<p><strong>Intelligent RCQ<\/strong><\/p>\n\n\n\n<p>From designing process digitalization strategies to implementing leading digital solutions, we help you gain mastery over your compliance activities. Improve performance, de-risk and accelerate your investments.<\/p>\n\n\n\n<p><strong>RCQ managed services<\/strong><\/p>\n\n\n\n<p>We transform and manage complex regulatory and quality processes, enabling you to focus on core activities. Call one of our experts to share your challenges and questions, and let us help you accelerate your time to care.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/section>\n\n\n\n<section class=\"wp-block-cg-blocks-wrapper-people-slider section section--expert-slider wrapper-people-slider undefined\"><div class=\"container\"><div class=\"content-title\"><h2 data-maxlength=\"34\" class=\"people-heading-title\">Meet our experts<\/h2><\/div><\/div><div class=\"slider slider-boxed\"><div class=\"container\"><div class=\"slider-window\"><div class=\"slider-list\">\t\t<div class=\"slide\">\n\t\t\t<div class=\"box\">\n\t\t\t\t<div class=\"row\">\n\t\t\t\t\t<div class=\"col-md-6 col-lg-4 box-img-wrapper\">\n\t\t\t\t\t\t<img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.capgemini.com\/ca-en\/wp-content\/uploads\/sites\/17\/2022\/01\/Frederic-Burger-Ph.D.jpg\" alt=\"Fr\u00e9d\u00e9ric Burger Ph.D.\"\/>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div class=\"col-md-6 col-lg-8 box-inner\">\n\t\t\t\t\t\t<div class=\"row title-social-media-header\">\n\t\t\t\t\t\t\t<div class=\"col-md-12 col-lg-6 mbl-social-icon\">\n\t\t\t\t\t\t\t\t<ul class=\"social-nav\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li>\n\t\t\t\t\t\t\t\t\t\t\t<a class=\"subnav-button--form\" href=\"javascript:void(0)\" aria-label=\"contact us\" data-bs-toggle=\"modal\" data-bs-target=\"#WPB60ba3e1d_f426_428d_83d6_ea53177746ec\" data-bs-expert-title=\"1\">\n\t\t\t\t\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"ico-form\"><\/i>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><a aria-label=\"Linkedin\" target=\"_blank\" title=\"Opens in a new window\" href=\"https:\/\/www.linkedin.com\/in\/fr\u00e9d\u00e9ric-burger-96006413\/\"><i aria-hidden=\"true\" class=\"icon-li\"><\/i><\/a><\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"col-md-12 col-lg-6 box-container\">\n\t\t\t\t\t\t\t\t<div class=\"box-title\">\n\t\t\t\t\t\t\t\t\t<h3 class=\"people-profile-title\">Fr\u00e9d\u00e9ric Burger Ph.D.<\/h3>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span>CTO Life Sciences and Regulatory Affairs, Global Life Sciences Center of Excellence Leader, Capgemini Engineering<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"col-md-12 col-lg-6 social-box-container dkt-social-icon\">\n\t\t\t\t\t\t\t\t<ul class=\"social-nav\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li>\n\t\t\t\t\t\t\t\t\t\t\t<a class=\"subnav-button--form\" href=\"javascript:void(0)\" aria-label=\"contact us\" data-bs-toggle=\"modal\" data-bs-target=\"#WPB60ba3e1d_f426_428d_83d6_ea53177746ec\" data-bs-expert-title=\"Fr\u00e9d\u00e9ric Burger Ph.D.\">\n\t\t\t\t\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"ico-form\"><\/i>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><a aria-label=\"Linkedin\" target=\"_blank\" title=\"Opens in a new window\" href=\"https:\/\/www.linkedin.com\/in\/fr\u00e9d\u00e9ric-burger-96006413\/\"><i aria-hidden=\"true\" class=\"icon-li\"><\/i><\/a><\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"people-info\">Leading the global life sciences portfolio and solutions in Pharma and Medical Devices \u201cThis is undoubtedly a new stage in the use of data in the life sciences industry. With the combination of Regulatory Sciences and a clear strategy on Digital implementation, the data is now at the core of any new journey. We support our clients with expertise, strong assets and methodologies for accelerating their transformation\u201d.  \n\n <\/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\t\t\t\t<div class=\"modal\" id=\"WPB60ba3e1d_f426_428d_83d6_ea53177746ec\">\n\t\t\t\t\t<div class=\"modal-dialog modal-dialog-centered modal-lg modal-dialog-scrollable landing-page-modals\">\n\t\t\t\t\t\t<div class=\"modal-content\">\n\t\t\t\t\t\t\t<div class=\"modal-header\">\n\t\t\t\t\t\t\t\t<button type=\"button\" class=\"btn-close\" aria-label=\"close\" data-bs-dismiss=\"modal\"><\/button>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"modal-body\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"logo-wrapper\">\n\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.capgemini.com\/ca-en\/wp-content\/themes\/capgemini2025\/assets\/images\/capgemini-engineering.svg\"\n\t\t\t\t\t\t\t\t\t\talt=\"Connect with us\" class=\"light\" \/>\n\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.capgemini.com\/ca-en\/wp-content\/themes\/capgemini2025\/assets\/images\/capgemini-engineering-white.svg\"\n\t\t\t\t\t\t\t\t\t\talt=\"Connect with us\" class=\"dark\" \/>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h4 class=\"form-title\">Connect with us<\/h4>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t<div class=\"mf_forms__container \">\n\t\t\t\t\t\t\t\t<form id=\"mf_form_344241_4254420424\" class=\"mf_form__form row needs-validation\" action=\"\" method=\"post\" enctype=\"multipart\/form-data\" data-nosnippet>\n\n\t\t\t\t\t\t\t\t<input type=\"hidden\" name=\"form_id\" data-validate=\"number\" class=\"mf_form__id\" value=\"344241\" \/>\n\t\t\t\t<input type=\"hidden\" name=\"form_title\" class=\"mf_form__title\" value=\"\" \/>\n\t\t\t\t<input type=\"hidden\" name=\"wp_rest_nonce\" class=\"mf_form__wp_rest_nonce\" value=\"3c759546e9\" \/>\n\n\t\t\t\t<input type=\"hidden\" name=\"mf_form_conditional_logic\" class=\"mf_form__title conditional_logic\" value=\"\" \/>\n\t\t\t\t\n\t\t\t\t<input type=\"hidden\" name=\"mf_form_fields_country_dpo_field\" class=\"mf_form__title conditional_logic mf_form_fields_country_dpo_field\" value=\"\" \/>\n\n\t\t\t\t<!-- Anti-spam field -->\n\t\t\t\t<input type=\"text\" \n\t\t\t\t\tname=\"website_url\" \n\t\t\t\t\tclass=\"mf_field__url\" \n\t\t\t\t\tautocomplete=\"off\"\n\t\t\t\t\ttabindex=\"-1\"\n\t\t\t\t\taria-hidden=\"true\"\n\t\t\t\t\tstyle=\"position:absolute;left:-9999px;width:1px;height:1px;opacity:0;pointer-events:none;\" \n\t\t\t\t\/>\n\t\t\t<\/form>\n\n\t\t\t<div class=\"mf_form__success\" tabindex=\"0\" role=\"alert\">\n\t\t\t\t\t\t\t\t<p>Thank You! 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https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Regulatory Affairs, Compliance and Quality - Capgemini Canada - English<\/title>\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.capgemini.com\/ca-en\/solutions\/regulatory-affairs-compliance-and-quality\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Affairs, Compliance and Quality\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.capgemini.com\/ca-en\/solutions\/regulatory-affairs-compliance-and-quality\/\" \/>\n<meta property=\"og:site_name\" content=\"Capgemini Canada - English\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-03T11:48:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.capgemini.com\/ca-en\/wp-content\/uploads\/sites\/17\/2022\/07\/Capgemini_Solutions_Regulatory-Affairs-Compliance-and-Quality.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2880\" \/>\n\t<meta property=\"og:image:height\" content=\"1800\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.capgemini.com\/ca-en\/solutions\/regulatory-affairs-compliance-and-quality\/\",\"url\":\"https:\/\/www.capgemini.com\/ca-en\/solutions\/regulatory-affairs-compliance-and-quality\/\",\"name\":\"Regulatory Affairs, Compliance and Quality - 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