Bespoke regulatory services for fast approval

Orphix regulatory consultants advise clients on how they can improve early patient access to innovative medicinal products through expedited pathways in Europe and the US. Orphix has in-depth knowledge of:

  • EU: Priority Medicines (PRIME) programme, accelerated assessment and conditional marketing authorisation in the centralised procedure
  • UK: Early Access for Medicines Scheme (EAMS)
  • US: Fast-track and Breakthrough therapy designations, accelerated approval, priority review.