High quality documentation from expert scientists and regulatory consultants

Orphix regulatory consultants support clients with writing, reviewing, formatting and submitting a wide range of documents and dossiers including:

  • Meeting package and briefing package for European Medicine Agency (EMA), Food and Drug Administration (FDA) or European national regulatory agencies
  • Orphan drug designation application
  • Investigational New Drug (IND) overviews and summaries (in close cooperation with trusted US agents)
  • Investigator brochure
  • Paediatric Investigation Plan (PIP)
  • Investigational Medicinal Product Dossier (IMPD)
  • Environmental Risk Assessment (ERA)
  • Submission modules: 
    • Modules 1 and 2 for Marketing Authorisation Application (MAA) in the European Union (EU)
    • Module 2 for New Drug Application (NDA) in the US (Food and Drug Administration – FDA)