Regulatory Science & Strategy

  • Scientific Advice- registration, documentation and support
  • Preparation of responses to deficiency letters and queries from regulatory authorities
  • Defining the strategy to address the concerns raised in Deficiency letters from RAs
  • Referrals – preparation of response documents, documentation and support
  • Assistance during meetings with EMA and Local Authorities in Europe
  • Selection of marketing authorization procedures
  • PIP Waiver / PIP Referral / Orphan designation
  • Scientific writing