ClarkeModet has appointed Fernanda Manhães as its new Regulatory Services Director in Brazil, strengthening its ability to support healthcare companies in an environment marked by increasing regulatory demands and ever more critical timelines for market entry and continued presence in the Brazilian market.
With more than 15 years of international experience in Regulatory Affairs, Fernanda will be responsible for leading and developing this area within the company, supporting highly complex projects across the pharmaceutical, biotechnology, veterinary, and medical devices segments.
Fernanda Manhães is a qualified pharmacist, with a master’s degree in Health Economics and Pharmacoeconomics, and has built her professional career in Brazil and across European markets, working with leading international companies such as Chiesi Farmaceutici, Neurocrine Biosciences, Almirall, and ImmunoGen. In addition, she has collaborated directly with regulatory authorities such as Anvisa and other leading international agencies, participating in clinical development projects, registrations, variations, and regulatory strategy. She also brings experience leading regulatory projects in areas such as rare diseases, innovative medicines, and products with high technological complexity.
The appointment comes at a particularly significant time for the sector in Brazil, which currently concentrates nearly 50% of all clinical trials in Latin America and operates under an increasingly technical and demanding regulatory framework. This environment is defined by new Anvisa regulations and the agency’s digital transformation process, underscoring the growing importance of a well‑designed regulatory strategy for companies aiming to reduce risk and successfully bring their products to market.
“At ClarkeModet, we work to ensure that regulation acts as a market access enabler and is fully integrated into each organization’s overall strategy,” says Fernanda Manhães. “Data can generate evidence, but regulatory authorities need to hear the story behind it. Here, we understand that Regulatory Affairs is not just about compliance, but about strategy.”
With this appointment, ClarkeModet strengthens its position in Brazil, consolidating Regulatory Services as a core pillar of its offering to healthcare companies across all stages of the innovation lifecycle.