Needed expertise for regulatory strategy and support for execution for CP and PUMA formulation

  • A small European pharmaceutical company has identified the need for support due to lack of capacity and capability to process a centralized procedure for a PUMA formulation.
  • PharmaLex offered support for various regulatory activities in relation to the preparation, submission and coordination of the centralized procedure.
  • Project management.
  • Definition and tracking of KPIs and budget.