Regulatory Affairs provide strategic and operational directions and support for working within regulations, in order to adapt and expedite the development and delivery of safe and effective medicinal products.
The continuous scientific progresses need to be taken into account to interpret regulatory requirements.
Our Regulatory Affairs department is focused on biologic and biotech medicinal products and more specifically Advanced Therapy medicinal Products (ATMPs).
ATMPs requires specific, innovative, flexible and custom-made regulatory approaches. In other words, business objectives. Today, ATMP regulations and guidelines have to be read in conjunction with each product’s characteristics and mode of action, at every steps of the development.
GenoSafe can provide you with a number of consulting services including:
- 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