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.