PHARMACEUTICALS
- 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
