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
- 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 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.
Head of Regulatory Affairs Sweden
+46 70 165 22 77
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."