Regulatory intelligence and senior advisory for pharmaceutical, biotech and MedTech pathways in Russia.
Russia regulatory coverage
Pharegis supports market-entry and lifecycle work in Russia across medicinal products, APIs and CMC, EAEU GMP inspection readiness, clinical and preclinical evidence, pharmacovigilance, medical devices and non-standard regulatory strategy.
Relevant technical guidance
- Drug Registration in Russia under EAEU Rules: Dossier Strategy, Quality Expertise and Market Authorization
- EAEU Dossier Alignment after 31 December 2025: Transitional Cases and Portfolio Decisions
- Registration of Active Pharmaceutical Ingredients (API) in Russia
- EAEU Variations Management: Classification, Grouping and Lifecycle Control
- EAEU GMP Inspection and Certification for Foreign Pharmaceutical Manufacturers
- Medical Device Registration in Russia and the EAEU: Pathway, Evidence, QMS and Clinical Strategy
- Local Clinical Studies in Russia: Protocol Development, Ministry Approval and Vendor Strategy
- EAEU Pharmacovigilance: Marketing Authorization Holder, Vendor Selection and Sponsor Oversight
- Regulatory Consulting for EAEU Market Entry and Lifecycle