Regulatory Affairs Unit
Finding the Key for Regulatory Success
In the photo: Ana Patacão, Regulatory & Data Sciences Global Director
Our Regulatory Affairs unit provides regulatory strategy support guided by regulatory sciences, essential on today´s product development, and solutions on registration process in our main regions, Europe and Latin America.
Our highly experienced local teams are committed to deliver reliable solutions in line with local regulations, giving you the necessary guidance and support on registration procedures and post-approval activities.
Focused on your target, we provide unique regulatory intelligence and strategic insight, working with the highest quality standards, efficiency and reliability, in order to provide the best services and successful solutions.
From the regulatory strategy on the early product development to the marketing authorisation applications and post-marketing authorisation procedures, we ensure you the necessary guidance for regulatory compliance.
Whether you need a full regulatory service for a medicinal product or a unique regulatory advice for a medical device, Eurotrials can support you on the regulatory activities throughout the product life cycle.
Our regulatory affairs unit is engaged with various associations such as Pharmaceutical Regulation and Regulatory Professionals Association (APREFAR), Drug Information Association (DIA) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).