Maintaining Marketing Authorisations/
Regulatory Portfolio Management

Compilation of documents in compliance with
current legal requirements for:

  • National variations in Germany (as per AMG Section 29 and Section 105)
    and Austria
  • European variations for MRP, DCP and CP procedures
  • Changes in marketing authorisation holder/transfer of marketing
  • Marketing authorisation renewals (national and European)
  • Handling conditions placed on marketing authorisations

Project management:

  • Coordination and management of these procedures, including submission
    via the relevant national portals
  • Handling the content and technical aspects of authority opinions
    (e.g. deficiency letters)

Liaising with your technical departments, external partners and other service
providers, as applicable.