Regulatory expertise

Our regulatory team at your service

The Unither sites will provide you with their CMC expertise by offering you, in accordance with the requirements in force:

  • The drafting of IMPD/INDs,
  • The drafting of MA files (module 2.3 and 3) and technical files for medical devices (manufacturing part),
  • The drafting of pharmaceutical variations,
  • Answers to pharmaceutical questions from the authorities.



In addition, the teams will be able to advise you and propose pharmaceutical development strategies that meet regulatory requirements.