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Services
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.