Marketing authorisation applications

Creation of marketing authorisation documents in accordance
with the current legal requirements:

  • Compilation of complete marketing authorisation dossiers or single modules in
    CTD format for chemical substances, phytotherapeutics, homeopathic remedies
    and veterinary medicinal products
  • Reformatting of marketing authorisation documents from NtA to CTD format
  • Compilation of Module 3 – Quality (CMC) based on source data
  • Compilation of Module 2 – Summaries and Overviews
  • Creation of product information (summary of product characteristics [SmPC],
    package leaflet, labelling)

Project management:

  • Coordination and management of entire marketing authorisation procedures
    (national, MRP, DCP, CP) or individual parts for original marketing authorisations, generic drugs, parallel imports
  • 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 necessary