Assion

About Assion

We provide the strategic direction, local market knowledge, expertise and people needed to obtain successful Regulatory Affairs and Market Access outcomes within international markets.

Our coverage of the European market supports Life science companies in developing and implementing Regulatory and Market Access strategies on European and national level as required.

Our multi-disciplinary experts will facilitate and guide you through the most appropriate strategy to register your product in Europe. Our grounded expertise in managing European regulatory procedures together with an in-depth knowledge of the local requirements for a better regulatory strategy and understanding of the national cultural nuances is vital to your success.

Keywords

• Clinical Trials Applications
• E-Ctd
• Lifecycle Management
• Market Access
• Orphan Drug Designation
• Paediatric Investigation Plan Applications (Pip
• Readability User Testing
• Regulatory Affairs
• Regulatory Outsourcing
• Regulatory Strategy
• Scientific Advice
• Scientific Writing

Address

• Headquarters

  Luna ArenA, Herikerbergweg 238, 1101 CMAmsterdamNoord-Holland, Netherlands