Regulatory Affairs

Our Regulatory Affairs unit provides regulatory strategy support guided by regulatory science, which is essential in today’s product development, and offers solutions geared to the registration process in our main regions, Europe and Latin America.

Our highly experienced local teams are committed to delivering reliable solutions in line with local regulations, giving you the guidance and support you need with registration procedures and post-authorization maintenance activities.

Focusing on your target, we provide unique regulatory intelligence and strategic insight, working with the highest standards of quality, efficiency and reliability to provide you with the best services and successful solutions.

From regulatory strategies for early product development to marketing authorization applications and post-marketing authorization procedures, we provide you with the guidance you need for regulatory compliance.

Whether you need a full regulatory service for a medicinal product or one-time regulatory advice for a medical device, Eurotrials can help you navigate through the regulatory procedures during your product’s life cycle.

We also have the regulatory know-how for registration of cosmetics and food supplements with the appropriate health authorities.

Our solutions:
  • Regulatory Intelligence Services
  • Regulatory Submission Strategy
  • Marketing Authorization Applications (NP/MRP/DCP/CP)
  • Variations & Renewals
  • Labelling Services
  • Advertising and Promotion
  • Distribution Authorization Applications
  • Technical Direction