{"id":13240,"date":"2026-09-02T08:00:03","date_gmt":"2026-09-02T11:00:03","guid":{"rendered":"https:\/\/passarini.com.br\/eudamed-mandatory-medical-device-compliance-eu-2\/"},"modified":"2026-09-03T08:52:34","modified_gmt":"2026-09-03T11:52:34","slug":"clarkemodet-acquires-passarini-group-regulatory-affairs","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/clarkemodet-acquires-passarini-group-regulatory-affairs\/","title":{"rendered":"ClarkeModet Acquires Passarini Group to Expand Regulatory Affairs"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp\" alt=\"newsletter passarini\" width=\"1920\" height=\"500\" class=\"wp-image-7421\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h1><strong>ClarkeModet acquires Passarini Group to strengthen its global Regulatory Affairs offering<\/strong><\/h1>\n<h3><strong>The acquisition expands ClarkeModet&#8217;s regulatory capabilities and reinforces its position as a strategic partner for healthcare and life sciences organizations.<\/strong><\/h3>\n<p><strong>Madrid \/ Rio de Janeiro \/ S\u00e3o Paulo, September 1, 2026<\/strong> \u2013 ClarkeModet has acquired Passarini Group, a global regulatory affairs consultancy with offices in Brazil, Portugal, and the United States.<\/p>\n<p>The acquisition strengthens ClarkeModet&#8217;s Regulatory Affairs division and expands its capabilities across the pharmaceutical, biotechnology, medical devices, food, nutrition, and cosmetics sectors. The Group has added a team of 40 highly specialized professionals, enhancing its ability to support clients in Europe, the United States, and Latin America, where ClarkeModet already has a direct presence in 13 countries.<\/p>\n<p>Founded in Brazil in 2009, Passarini Group brings extensive international experience and a strong track record supporting companies before key regulatory authorities, including the U.S. Food and Drug Administration (FDA), Brazil&#8217;s National Health Surveillance Agency (ANVISA), as well as in CE marking procedures in the European Union. The company advises nearly 300 clients and operates in over 20 countries.<\/p>\n<p>Passarini Group also operates its own Contract Research Organization (CRO), GRINN, providing clinical research and trial services. This capability enables ClarkeModet to expand its patents and regulatory affairs offering into additional stages of the product development and market access journey for medicines and medical devices.<\/p>\n<p>\u201c<em>This acquisition marks another important step in our growth strategy and strengthens our ambition to become the leading global partner for innovative organizations<\/em>,\u201d said <strong>Mar\u00eda Gara\u00f1a, Global CEO of ClarkeModet<\/strong>. \u201c<em>By joining forces with Passarini Group, we are expanding our regulatory capabilities and enhancing our ability to support clients throughout the innovation journey, from development to market access and profitable growth.\u201d<\/em><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-image-element fusion-image-align-center in-legacy-container\" style=\"text-align:center;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"400\" height=\"500\" alt=\"ClarkeModet Acquires Passarini Group to Expand Regulatory Affairs\" title=\"feed BLOG Passarini-EN-ClarkeMod\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod-400x500.png\" class=\"img-responsive wp-image-13246\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod-200x250.png 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod-400x500.png 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod-600x750.png 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod-800x1000.png 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod.png 1080w\" sizes=\"(max-width: 800px) 100vw, 400px\" \/><\/span><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-margin-top:10px;\"><h3><strong>Expanding integrated innovation services<\/strong><\/h3>\n<p>The acquisition is aligned with ClarkeModet&#8217;s strategy of strengthening its integrated innovation services platform. With more than 145 years of experience, the Group provides comprehensive management of intangible and digital assets, alongside specialized services in Intellectual Property Consulting, Regulatory Affairs, and Funding &amp; Incentives.<\/p>\n<p>ClarkeModet is also currently evaluating additional acquisition opportunities to strengthen its different business lines across Europe and Latin America.<\/p>\n<p>\u201c<em>Life sciences companies face increasingly complex global regulatory requirements, and delays in securing approvals can have a significant impact on time-to-market and commercial performance<\/em>,\u201d said <strong>Clara Pombo, Global Head Regulatory Affairs at ClarkeModet<\/strong>. \u201c<em>This integration reinforces our commitment to delivering highly specialized regulatory advisory services built on local expertise and international reach. It will help our clients navigate complex regulatory environments and accelerate access to key markets across the United States, Europe, and Latin America.\u201d<\/em><\/p>\n<p><strong>Lucas M. Rodrigues, CEO of Passarini Group<\/strong>, added: \u201c<em>Joining ClarkeModet will allow us to accelerate our growth, expand our international reach, and offer our clients an even broader range of services. We share the same vision: helping innovative organizations succeed through technical excellence, regulatory expertise, and a truly international perspective.\u201d<\/em><\/p>\n<p>Passarini Group will be integrated into ClarkeModet&#8217;s Regulatory Affairs division and into the Group&#8217;s Brazilian organization, led by <strong>Claudio Castanheira<\/strong>. Its founders, <strong><a href=\"https:\/\/www.linkedin.com\/in\/lucas-rodrigues-2018\/\">Lucas<\/a> M. Rodrigues, <a href=\"https:\/\/www.linkedin.com\/in\/paulo-passarini-99a9873b\/\">Paulo<\/a> H. Passarini, and <a href=\"https:\/\/www.linkedin.com\/in\/clarissagrodrigues\/\">Clarissa<\/a> Rodrigues<\/strong>, will remain part of the leadership team.<\/p>\n<h3><strong>About ClarkeModet<\/strong><\/h3>\n<p>ClarkeModet is the leading IP y digital assets group in Spanish and Portuguese-speaking markets. With more than 145 years of experience, a direct presence in 13 countries across Europe and Latin America, and a team of more than 600 professionals, ClarkeModet helps innovative organizations protect, manage, and maximize the value of their intangible assets through specialized services in intellectual property, Regulatory Affairs, IP Consultancy, and Funding &amp; Incentives.<\/p>\n<h3><strong>About Passarini Group<\/strong><\/h3>\n<p>Passarini Group is an international consultancy specializing in regulatory affairs for the healthcare, in vitro diagnostics (IVD), hygiene, cosmetics, food, and sanitizing products sectors. Headquartered in S\u00e3o Paulo, the company provides regulatory support and compliance services across multiple international markets. The group integrates the structure and expertise of GRINN Company, a Contract Research Organization (CRO) specialized in conducting clinical trials and high-complexity scientific evaluations.<\/p>\n<p><strong>More Information<\/strong><\/p>\n<p><strong>Passarini Group<\/strong><\/p>\n<p>Rafaela Rodrigues<br \/>\n<em>Marketing Manager<\/em><br \/>\nE.: <a href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-stacked\" style=\"background-color:#f6f6f6;--awb-separator-border-sizes:0px;--awb-layout:row;--awb-alignment-small:space-between;--awb-stacked-align-small:center;\" data-title=\"ClarkeModet Acquires Passarini Group to Expand Regulatory Affairs\" data-description=\"ClarkeModet acquires Passarini Group to strengthen its global Regulatory Affairs offering\r\nThe acquisition expands ClarkeModet&#039;s regulatory capabilities and reinforces its position as a strategic partner for healthcare and life sciences organizations.\r\nMadrid \/ Rio de Janeiro \/ S\u00e3o Paulo, September 1, 2026 \u2013 ClarkeModet has acquired Passarini Group, a global regulatory affairs consultancy\" data-link=\"https:\/\/passarini.com.br\/en\/clarkemodet-acquires-passarini-group-regulatory-affairs\"><h4 class=\"tagline\" style=\"color:#333333;\">Share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fpassarini.com.br%2Fen%2Fclarkemodet-acquires-passarini-group-regulatory-affairs&amp;t=ClarkeModet%20Acquires%20Passarini%20Group%20to%20Expand%20Regulatory%20Affairs\" target=\"_blank\" 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