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