Bespoke regulatory services for optimal drug development

Orphix regulatory consultants provide upstream regulatory support to ensure high-quality and compliant submissions. Orphix facilitates agency reviews and liaises with national and international regulatory authorities to represent the best interests of its clients. Orphix supports:

  • Advice meetings with European Medicines Agency (EMA), Food and Drug Administration (FDA) or European national regulatory agencies
  • Clinical Trial Authorisation (CTA). Investigational New Drug (IND) applications
  • Marketing Authorisation Application (MAA) and New Drug Application (NDA)