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
  authorisations
• 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.