- Regulatory Strategies
- New Marketing Authorization Applications (MAA)
- Life cycle management, e.g., variations, renewal, product maintenance including CMC assessments/variations/presentation of suggestions for update and communication/negotiations with authorities
- Product information, translations into Danish (OTC and Rx)
- QC checks of SmPC, PIL and labeling documents (OTC and Rx)
- Artwork, mock-ups, print proofs (OTC and Rx)
- MAH-transfers
- Pharmaceuticals, medical devices, cosmetics, food supplements or nutrition
- Switch applications (Rx to OTC)
- Orphan Drug Designation
- Regulatory intelligence
- Due Diligence process
- Scientific Advise
Regulatory Affairs