3 dossiers  (an NDA and 2 MAA) for initial application for DP for prevention of pregnancy

  • Dossiers for EMA and FDA with differences in the requirements
  • Support for the client (one US NDA and one EU MAA) and their third-party collaboration partner (one additional EU MAA)
  • Differences in the administrative part of the dossiers and following updates of M1 and M2 documents
  • Short notice changes before the planned submission dates due to difficult alignment between affected parties