Regulatory Affairs

Decades of valuable experience in the approval of medications and medical products make us an effective partner for regulatory activities for your pharmaceutical products on the Austrian market.

  • Registration of medicinal products
    • Registration dossiers (creation, reformatting to CTD format)
    • Variations
    • Life cycle management
    • MRP and DCP approvals
    • Creation and update of SmPC and PIL
  • Registration of medical devices
    • Creation of dossiers
    • CE certifications
  • Pharmacovigilance
    • Post-market surveillance for medical products
    • Processing of side-effect reports
    • Eudravigilance (data entry)

If you require our expertise in connection with approval activities for medications and medical products, please contact:
DI Dr. B. Wittmann, b.wittmann et sigmapharm.at     Tel: +43-(0)1-330 0671-0