Global innovator company.
- Wanted to outsource parts of their mature product portfolio.
- >60 products in different therapeutic areas
- 430 MAs in Europe, 1,900 MAs internationally (incl. CN, AUS, CAN).
- Scope of PharmaLex support:
- Full regulatory product responsibility
- GRA CMC Manager
- All publishing and submission activities
- Piloting of PV and Medical Affairs interface.