ClarkeModet acquires Passarini Group
ClarkeModet has acquired Passarini Group, a regulatory affairs consultancy for the healthcare sector with a direct presence in Brazil, Portugal and the United States. The transaction, announced on September 2, 2026 in Madrid, Rio de Janeiro and São Paulo, strengthens ClarkeModet’s Regulatory Affairs division with the addition of a team of 40 specialized professionals and extends the group’s reach across the pharmaceutical, biotechnology, medical devices, food, nutrition and cosmetics sectors.
The acquisition brings Passarini Group’s operations into ClarkeModet’s existing structure, which already covers 13 countries across Europe and Latin America. Founded in Brazil in 2009, Passarini Group has built experience supporting companies before regulatory authorities including the US Food and Drug Administration (FDA) and Brazil’s National Health Surveillance Agency (ANVISA), as well as CE marking procedures in the European Union.
The company advises close to 300 clients across more than 20 countries and also runs its own Contract Research Organization, GRINN, which provides clinical research and trial services. That capability allows ClarkeModet to extend its patents and regulatory affairs offering into further stages of the product development and market access process for medicines and medical devices.
Passarini Group will be integrated into ClarkeModet’s Regulatory Affairs division and into the group’s Brazilian organization, led by Claudio Castanheira, Regional Managing Director Brazil at ClarkeModet. The consultancy’s founders, Lucas M. Rodrigues, Paulo H. Passarini and Clarissa Rodrigues, will remain part of the leadership team.
Strategic context
The move forms part of ClarkeModet’s strategy to build out an integrated innovation services platform that, alongside intellectual property consulting, now spans Regulatory Affairs and Funding & Incentives. María Garaña, Global CEO of ClarkeModet, and Clara Pombo, Global Head of Regulatory Affairs at ClarkeModet, framed the acquisition as a way to support clients across the development-to-market-access continuum, addressing the increasingly complex regulatory requirements facing life sciences companies in the United States, Europe and Latin America, where delays in securing approvals can affect time-to-market and commercial performance. ClarkeModet said it is evaluating further acquisition opportunities to strengthen its business lines across Europe and Latin America.
