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
