Regulatory Affairs Support in EAEU Region
Our experts are qualified scientists with extensive experience in the pharmaceutical industry and regulatory affairs.
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 and DCP registration, and post-registration variations 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:
- Dossier GAP analyses;
- 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.
