ClarkeModet acquires Brazil’s Passarini to expand healthcare regulatory services

ClarkeModet has acquired Brazil’s Passarini Group, adding 40 specialists and a consultancy serving approximately 300 clients in more than 20 countries. The transaction was announced on 2 September 2026. Financial terms were not disclosed.

The acquisition connects two areas of healthcare product development: protecting the intellectual property behind an innovation and meeting the requirements needed to bring it to market.

Founded in 2009 and based in Ribeirão Preto, São Paulo state, Passarini has developed an international business with operations in Brazil, Portugal and the United States. Its activities include healthcare product regulation, certification and support for quality and production processes.

Passarini will join ClarkeModet’s regulatory affairs division and its Brazilian operation, led by Claudio Castanheira. Founders Lucas Rodrigues, Paulo Passarini and Clarissa Rodrigues will remain in management.

The consultancy works with pharmaceutical and medical-device businesses, as well as companies in food, nutrition and cosmetics. Its services include support for procedures involving the US Food and Drug Administration (FDA), Brazil’s ANVISA, and CE marking requirements in Europe.

These are distinct regulatory systems. The commercial rationale for combining that expertise is to help clients coordinate product documentation and market-entry work across jurisdictions, rather than treating each country as an entirely separate project.

Passarini also brings GRINN, its contract research organisation, or CRO. This business provides clinical research services for medical-device manufacturers, pharmaceutical companies, universities and public institutions.

That capability extends the service offering beyond advice on patents and regulatory submissions. Clinical studies can generate evidence needed to assess a product’s performance and support its development, placing research work alongside the legal and technical services already available within the group.

The distinction between those activities remains important. A patent protects an invention against unauthorised use; it does not, by itself, authorise the sale of a medicine or medical device. Companies must separately meet the applicable health and product requirements.

In the European Union, CE marking indicates conformity with the relevant product legislation. Responsibility rests with the manufacturer, while the applicable assessment procedure determines whether an independent notified body must participate. Acquiring a regulatory consultancy does not change those obligations.

For European healthcare companies considering expansion into Brazil, the combined offering could provide a way to coordinate intellectual property protection with local regulatory preparation. Passarini’s European operation also supports the reverse route, assisting businesses seeking to enter the EU market.

The transaction continues a diversification strategy at ClarkeModet, which was founded in Spain in 1879. Its established business covers patents, trademarks and other intangible assets. In 2023, it acquired Arosa I+D, adding expertise in innovation grants, public funding and tax incentives.

Together, these activities suggest a business model aimed at supporting several stages of innovation: financing development, protecting its results and preparing products for commercialisation.

Global chief executive María Garaña said the acquisition would broaden support throughout clients’ innovation cycles. Passarini chief executive Lucas Rodrigues expects the combination to expand the consultancy’s international reach and service offering.

ClarkeModet is also assessing further acquisitions, including opportunities to strengthen its businesses in Europe.