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