Drug Regulatory Affairs

Our services in the field of Drug Regulatory Affairs essentially include:

Medicinal product marketing authorisations / Articles 8(3) and 19 (a, b, c) of Regulation 2001/83EC).

  • Centralised and decentralised European marketing authorisation procedures (CP, DCP / MRP, NP)
  • Variations
  • National phase, translations
  • Product information texts
  • Communication with national authorities
  • Advice on regulatory strategy


  • Document review
  • Submission
  • Defect handling

Alert Management in NMVS

  • Alert management
  • Contract initiation with the required suppliers
  • Trouble shooting

IFA notifications (PZN)

  • Customer registrations
  • PZN new admissions
  • Price changes
The letters "AMG §§" which stands for the german drug law and a picture of our Regulatory Manager