Regulatory Affairs

  • Preparation of registration dossier (DCP/MRP/NP) and related documents
  • Maintenance and life-cycle management of marketing authorizations (Variations, Renewals, etc.)
  • eCTD preparation, publishing and regulatory compliance
  • Local contact for registration processes
  • Regulatory Consulting and Advice meetings
  • Compilation of ASMF for APIs
  • CEP submissions