Regulatory Activities

  • Regulatory strategy, Guidance & Support
  • Registration dossier development and upgrade (Module 1 – Module 5)
  • Advice on national or EU regulation for drugs and medical devices
  • Compilation and submission of Marketing Authorisation applications/renewal applications to Regulatory Authorities
  • Filing Variations
  • Medical writing and updating (labelling, leaflets, and SmPC)
  • Regulatory compliance for food supplements
  • Writing of PSUR and RMP
  • Expert advice on PV system requirements, PV trainings for PV and non-PV personnel
  • Providing QP for Pharmacovigilance and for Materiovigilance
  • Preparation and submissions for regulatory approvals for clinical studies
  • Review (regulatory requirements) and submission of promotional materials to Regulatory Authorities
  • Electronic submissions in eCTD and non0eCTD electronic submission (NEES) and conversion from CTD to eCTD
Go Back