Regulatory Services

Marketing Authorization

Project discussion in Life Science

Marketing Authorization

We provide end-to-end regulatory support, ensuring compliance, efficiency and market access across the Nordic region and beyond. With deep expertise in regulatory frameworks, we streamline processes, manage interactions with authorities, and facilitate product approvals and lifecycle management. Our multilingual capabilities and strategic insights help clients navigate complex regulatory landscapes with confidence, enabling successful product launches, expansions, and ongoing compliance.

Beatrice Öström and Sponsor oversight expert

Our Services:

  • New Marketing Authorisation Applications (MAA)
  • Maintenance of Marketing Authorisations 
  • Update and translations of local language materials to and from all Nordic languages (Swedish, Danish, Norwegian, Finnish, Icelandic):
    • Product information (SmPC
    • PIL, labelling)Artworks and mock-ups
    • Educational material
    • Marketing material
  • MRP/DCP/national and centralized procedure
  • Regulatory agency interactions
  • CMC (variation assessments and documentation)
  • Variations, renewals, article 61(3) notifications, MAH transfers
  • OTC Switch applications (Rx to OTC)
  • Geographical expansion
  • Regulatory project management
  • Regulatory intelligence
  • Due diligence
  • eCTD

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