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Medical Affairs & Market Access

Regulatory & Medical Development

Headed by Louise Søe Bak, the Medical Affairs & Market Access Team consists of regulatory affairs specialists with considerable expertise and in depth scientific knowledge within medical affairs and market access activities for cosmetics, food supplements, pharmaceutical and biological products.

The Medical Affairs & Market Access team:

  • provides early stage development consultancy on medical affairs and market access strategies
    • prepares Target Product Profile (TPF)
    • evaluates label and market impact based on results from preclinical and clinical studies
  • prepares and reviews Module 1-5 documentation related to medical affairs and market access for pharmaceutical and biological products
    • provides national M1 translation
    • prepares Company Core Data Sheet
    • prepares Risk Management Plan
    • prepares authority responses
    • prepares lay language sections for Clinical Trial Application and Risk Management Plan
    • performs medical and scientific review of labelling
  • prepares and reviews documentation for cosmetic and food supplement for medical affairs and market access activities
    • provides labelling for food supplements and cosmetics
    • prepares Product Information File and notification to the Cosmetic Products Notification Portal
  • provides market access activities such as reimbursement, medicinal list documentation, pricing and upload of labelling information
  • provides marketing compliance activities
    • reviews marketing material
    • provides abbreviated product information for pharmaceutical/biological products, cosmetics and food supplements
  • provides medical affairs activities such as pharmacovigilance and medical information

For more information about medical affairs and market access services, please contact Louise Søe Bak.