Empowering your achievement in Eastern European pharma markets

Full support to maintain regulatory approvals and optimize product maintenance

Grove Group CEE partners’ in-depth market knowledge and established contacts with local healthcare authorities enable marketing authorization holders to maximize their business performance.

  • Management of existing marketing authorizations throughout the Eastern European region
  • Preparation and management of maintenance application
  • Variation submissions (manufacturing, labelling changes etc.)
  • Renewals
  • Notifications
  • Safety updates
  • Support for the management of national Agency databases
  • Assistance with the submission of annual specific national declarations
  • Support for compassionate use process