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.

Production of commercial batches

Analytical development