The acquisition expands ClarkeModet's regulatory capabilities and reinforces its position as a strategic partner for healthcare and life sciences organizations.
Madrid / Rio de Janeiro / São Paulo, September 2, 2026 ? ClarkeModet has acquired Passarini Group, a global regulatory affairs consultancy with offices in Brazil, Portugal, and the United States.
The acquisition strengthens ClarkeModet's Regulatory Affairs division and expands its capabilities across the pharmaceutical, biotechnology, medical devices, food, nutrition, and cosmetics sectors. Through the integration, the Group adds a team of more than 30 highly specialized professionals, further enhancing its ability to support clients worldwide.
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'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.
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.
?This acquisition marks another important step in our growth strategy and strengthens our ambition to become the leading global partner for innovative organizations,? said María Garaña, Global CEO of ClarkeModet. ?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.?
Expanding integrated innovation services
The acquisition is aligned with ClarkeModet'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 & Incentives.
ClarkeModet is also currently evaluating additional acquisition opportunities to strengthen its different business lines across Europe and Latin America.
?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,? said Clara Pombo, Global Head Regulatory Affairs at ClarkeModet. ?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.?
Lucas M. Rodrigues, CEO of Passarini Group, added: ?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.?
Passarini Group will be integrated into ClarkeModet's Regulatory Affairs division and into the Group's Brazilian organization, led by Claudio Castanheira. Its founders, Lucas M. Rodrigues, Paulo H. Passarini, and Clarissa Rodrigues, will remain part of the leadership team.
About ClarkeModet
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 & Incentives.
About Passarini Group
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 São 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.
