Regulatory affairs


Commercial expert recruitment team for Pharmaceuticals


In-house and consultancy regulatory services specialized in pharmaceutical products at all the different levels of the product cycle. 

Our consultants have a long track record working locally and internationally with diverse specialties. 

  • Nordic Regulatory Partner, New Marketing Authorization Applications (MAA), CMC assessments, MAH-transfers, Due Diligence process
  • Launches, geographic expansions
  • Coordinate global partners, facilitate local requirements
  • Switch applications (Rx to OTC)
  • Orphan Drug Designation
  • Initial Clinical Trial applications and substantial amendments (SA)
  • Regulatory intelligence
  • Compliance
  • Due Diligence process
  • Scientific Advise
  • Authority interactions

Beatrice Öström and Sponsor oversight expert

Life cycle management

  • Variations, renewal, product maintenance
  • Product information, translations (Swedish, Danish, Norwegian, Finnish)
  • QC checks of SPC, PIL and labeling documents
  • Artwork, mock-ups, print proofs, approval and annotation for submission
  • FASS, Felleskatalogen, Pharmaca Fennica, DKMA-net, vnr, LiiV, Farmalogg

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