Regulatory Affairs

  • Support in development of regulatory affairs strategies for NCEs and generics
  • Scientific advice management
  • Building Modules 2.3S, 2.3P and M3 of eCTD for IND/IMPD/NDA/ANDA and EU registration dossiers
  • RA support during product development of CMC dossier parts
  • Due Diligence on CMC part of registration dossiers (NDA/ANDA/EU) in view of licensing-in or initial submissions
  • Drafting of Paediatric Investigation Plans
  • EU Submission management (CTAs/MRP/DCP/CP)
  • Product life-cycle management, e.g. submission of variations, renewals and/or line extensions