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