Empowering your achievement in Eastern European pharma markets

Obtaining MA approvals and MAH transfers in Eastern European countries

Grove Group provides local regulatory excellence and resource throughout all stages of product marketing authorization process and guarantees efficient approval process.

  • Evaluation and support with optimising submission dossiers
  • Submission of documentation for new marketing authorizations and MAH transfers
  • Management of a broad range of application types (DCP, MRP, NP) in accordance with the latest requirements
  • Maintaining close contact with local agencies to monitor MA application progress
  • Review of the local language Patient Information Leaflets (PIL)
  • Carton/label artwork, mock-ups review; full alignment to national requirements
  • Readability testing of package leaflets
  • Packaging material submissions
  • Labeling compliance and approval