Regulatory Strategy

  • Drug Regulatory Intelligence – latest regulatory information from our Global Network of Partners about the constantly changing regulatory environment in 90 countries of the world
  • Choice of the best pathways for authorization in the European Union
    • DCP - choice of reference/concerned member states
    • CP - Advisement on all preliminary and in-process procedures including preparation of relevant documents
    • Orphan Designation
    • PIP Waiver / PIP Deferral
  • Preparation of responses to deficiency letters and queries from Regulatory Authorities
  • Assistance during Meetings with EMA/NCAs, Scientific Advice and Referrals – preparation of briefing package, documentation and support
  • Defining the strategy to address the concerns raised in Deficiency letters from RAs