We help you identify the regulations applicable to your projects.
Early identification and navigation of regulatory requirements can power your business to advance and be ultimately a competitive advantage.
With our market knowledge and our strategic vision, we guide you throughout the whole life cycle of your project: from the research and development phases up to commercialization for human, veterinary or cosmetic uses.
In the context of the highly regulated environment applicable for life sciences products, multiple criteria should be considered at the time of putting together communications such as the regulatory status of the product, the potential recipients of the information 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)