Regulatory affairs (RA) support aims to define the best way for a biotech company to develop, register, and maintain its product on the market. That includes implementing a regulatory strategy for fast-track access to market.
- Gap analysis report
- Consulting and advice, including RA strategy and development
- Operational support: Prepostmarketing-authorization activities, clinical operations, and interactions with health authorities
- RA operations such as clinical trial application, operational due diligence, scientific advice, pediatric investigation plan (PIP), presubmission meeting, and good manufacturing practice (GMP) clearance
- Regulatory intelligence (local requirements)
- Registration dossier and publishing
- RA planning and execution follow-up