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