Regulatory Affairs

We can support you with

  • Regulatory Strategies
  • New Marketing Authorization Applications (MAA)
  • Life cycle management, e.g. variations, renewal, product maintenance
  • CMC assessments and creation of CMC document
  • 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
  • Nordic partner
  • FASS, Felleskatalogen, Pharmaca Fennica, DKMA-net, vnr, LiiV, Farmalogg
  • MAH-transfers
  • Coordinate global partners, facilitate local requirements
  • Pharmaceuticals, medical devices, cosmetics, food supplements or nutrition
  • Switch applications (Rx to OTC)
  • Orphan Drug Designation
  • Regulatory intelligence
  • Due Diligence process
  • Scientific Advise

We can also provide other services, please contact us for a discussion on how we can help you.

Our team

Our team has a long and broad experience from HQ and affiliates, small pharma companies and global pharma companies, vaccines, biologicals, medical device, cosmetics, food supplements and nutrition, Rx, OTC, generics, parallel import/distribution.

We work together to find flexible solutions and help you meet your deadlines, all hands on deck when required.

Helena Björkman
Head of Regulatory Affairs Sweden
and Nordics
+46 70 165 22 77

Lisbeth Thyregod
Head of Regulatory Affairs and
Quality Assurance Denmark
+45 4130 8660

"PharmaRelations has supported us with regulatory support for the Nordic markets. I appreciate the professionalism, the high quality, the engagement and also the commitment to keep agreed timelines."