Bespoke regulatory services for SMEs

Orphix is an SME designated company with the European Medicines Agency (EMA). It is able to access SME incentives on behalf of SME qualifying companies that are not currently established in the European Union (EU) but need to access scientific advice on their development plans and on their submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA). Orphix can provide:

  • Advice on the criteria for SME designation
  • Preparation and review of documents for SME 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.