We help you identify the regulations applicable to your projects.
When regulatory requirements are identified at the very beginning of a project they become valuable assets. With our market knowledge and our strategic vision, we guide you throughout the life of your project: from the research and development phases up to commercialization for human, veterinary or cosmetic uses.
As a highly regulated sector, communication around health products is assessed according to the status of the product, the recipients of the information and/or the supports as well as the reimbursement by the social security.
Among our interventions:
- Regulation of health products, pharmaceutical liabilities
- Implementation of clinical trials, “unique convention”
- Support to early access to the market: temporary use of authorization, innovation package
- Drafting of contracts for clinical trials, safety data exchange agreement, collaboration,
- Relations with the authorities: French Drug Agency (ANSM), Regional Health Agencies, (ARS), DGCCRF, (inspections, injunctions, inquiries)