Bespoke regulatory services for companies developing drugs for rare diseases
Orphix has extensive experience with orphan drugs and supports clients during all stages of orphan drug development. Orphix can provide:
- Advice on the criteria for orphan drug designation in EU and US
- Preparation and submission of documents for orphan drug designation applications
- Full support from the initial designation to the final marketing authorisation
- Application and holding of the designation on behalf of non-EU clients.