Regulatory Affairs provide strategic and operational guidance as well as support for ensure product compliance with current regulations. The aim is to adapt and accelerate the development and marketing of safe and effective medicines.
Our expertise is focused on biological and biotechnological drugs and more particularly on Advanced Therapy medicinal Products (ATMPs). ATMPs require a specific, innovative, flexible and tailor-made regulatory approach. The regulations and specific guidelines of the ATMPs must be interpreted and take into account the characteristics of each product at all stages of its development.
- Product classification according to the European and North American regulations
- Regulatory strategy advice for the development, manufacturing and control of Advanced Therapy Medicinal Products and other Biologics
- Administrative support:
- Registration as a SME with the European Medicines Agency
- GMOs declarations according to the French regulation
- Biobanking declaration in France