Regulatory Strategy

  • Preparation of responses to deficiency letters and queries from regulatory authorities
  • Assistance during meetings with EMA and Local Authorities in Europe
  • Choice of the best pathways for authorization
    • DCP - choice of reference/concerned member states
    • CP - Advisement on all preliminary and in-process procedures including preparation of relevant documents
    • Orphan Designation
    • SME registration
  • Scientific Advice - registration, documentation and support
  • PIP Waiver / PIP Deferral
  • Orphan designation