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.