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Market Access & Life Cycle Management

Regulatory & Medical Development

The Market Access & Life Cycle Manage Team consists of experienced regulatory affairs specialists having in depth scientific knowledge within regulatory affairs, medical affairs and market access activities for cosmetics, food supplements, herbal, veterinary and human medicinal products.

By combining strategic, scientific and operational expertise, we ensure successful market access and maintenance of all our client’s products.

The Market Access & Life Cycle Management Team:

  • Provide early stage development consultancy on medical affairs and market access strategies, including:
    • Prepare Target Product Profile
    • Evaluate label and market impact based on results from non-clinical and clinical studies
  • Provide market access activities such as reimbursement, medicinal list documentation, pricing, ATC application, catalogue text and upload of labelling information
  • Provide marketing compliance activities, such as:
    • Review of marketing material
    • Prepare abbreviated product information
  • Manage all steps involved in life cycle management procedures, including variations, renewals, and de-registrations
  • Provide regulatory project management
  • Provide guidance and regulatory strategies for life cycle management activities
  • Conduct scientific advices with Health Authorities and/or Health Technology Assessment Bodies
  • Prepare, compile and submit all types of regulatory documents and dossiers in EU, CH, US, and CA, including ASMFs and DMFs
  • Prepare and review Module 1-5 documentation, including:
    • Provide translations of national Module 1 documents
    • Prepare Company Core Data Sheet
    • Prepare Risk Management Plan
    • Prepare responses to Health Authorities
    • Perform medical and scientific review of labelling
  • Prepare lay language summaries for Clinical Trial Applications and Risk Management Plans
  • Provide medical affairs activities within pharmacovigilance and medical information, such as:
    • Prepare, submit and track DSUR/PSUR
    • Literature search to identify literature reports containing ICSRs or other safety relevant information
    • Prepare Educational Materials, and Dear Doctor letters
    • Handle medical information inquiries
  • Prepare, review and submit documentation for cosmetic and food supplements
  • Review of marketing material for cosmetic and food supplements

For more information about our team and services, please contact Lisbeth Lyme, Head Market Access & Life Cycle Management.