ClarkeModet acquired Passarini Group, a global consultancy specializing in regulatory affairs for the health sector, with a direct presence in Brazil, Portugal and the United States.
The acquisition strengthens ClarkeModet’s Regulatory Affairs division and expands its capabilities to serve pharmaceutical, biotechnology, and medical device companies, as well as the food, nutrition, and cosmetics sectors. The Group adds a team of 40 highly specialized professionals, reinforcing its ability to support clients in Europe, the United States, and Latin America, where ClarkeModet already has a direct presence in 13 countries.
Founded in Brazil in 2009, Passarini Group brings a strong international track record with experience before regulatory bodies such as the FDA in the United States, ANVISA in Brazil, and in European regulatory bodies, as well as in procedures related to CE marking. It advises nearly 300 clients and operates in more than 20 countries. Passarini Group also has GRINN, its own CRO, which provides clinical research and trial services. This partnership allows ClarkeModet to expand its patent and regulatory affairs offering to other key phases of market entry for medicines and medical devices.
According to María Garaña, Global CEO of ClarkeModet, “this acquisition represents another step in our growth strategy and strengthens our goal of becoming the leading global partner for managing the intellectual property of innovative organizations. With Passarini Group, we enhance our capabilities in Regulatory Affairs and expand our value proposition to support our clients throughout their entire innovation cycle.”
A comprehensive model for innovative companies
This acquisition is part of ClarkeModet’s growth strategy, focused on expanding its capabilities in comprehensive innovation services. With over 145 years of experience, the Group offers comprehensive management of intangible and digital assets, as well as specialized consulting services in Intellectual Property, Regulatory Affairs, and Funding & Incentives. The Group is currently exploring further acquisitions to strengthen its various business lines in Europe.
As Clara Pombo, Global Head of Regulatory Affairs at ClarkeModet, points out, “Life Sciences companies operate in an increasingly complex and global regulatory environment, where every day of delay in bringing a product or device to market translates into millions of dollars in losses. With this integration, we continue our commitment to highly specialized global regulatory advice based on local knowledge. This will facilitate our clients’ time to market, especially in complex regulatory environments such as those in the United States, Europe, and Latin America.”
For his part, Lucas M. Rodrigues, CEO of Passarini Group, added that “the merger with ClarkeModet will allow us to accelerate our growth, expand our international reach, and offer our clients an even more comprehensive service. We share the same vision: to support innovative organizations with the utmost technical rigor and a truly international perspective.”
Passarini Group will be integrated into ClarkeModet’s Regulatory Affairs division and the Group’s structure in Brazil, led by Claudio Castanheira. Its founders—Lucas M. Rodrigues, Paulo H. Passarini, and Clarissa Rodrigues—will continue to be part of the management team.
