Regulatory Affairs Support in EAEU Region
Our experts are qualified scientists with extensive experience in the pharmaceutical industry and clinical research.
We provide registration procedure services in all Eurasian Economic Union countries, starting from medical writing and the preparation of pharmaceutical product documents in accordance with local requirements to dossier submission for Marketing Authorization, full procedure management in MRP, DCP, and RVP registration, and pharmacovigilance services after the completion of registration procedures.
Based on Biomapas substantial expertise, we can guide you through all necessary steps of medicinal product registration in the Eurasian Economic Union regionDossier GAP analyses;
- Pre-RVP national variations and EAEU variations evaluation, full procedure management;
- Dossier preparation for submission;
- Local Normative document preparation;
- EAEU labelling preparation;
- Medical and CMC writing;
- Readability User Testing;
- EAEU GMP inspection support/application submission;
- MRP, DCP, RVP, full procedure management.
All Post-Authorization Services
Ensuring regulatory compliance.