Historical Pharegis regulatory articles retained for reference and continuity of established search-engine URLs. For current regulatory guidance, use the main Expertise and Insights sections.
Reference
Archive Articles
Historical publications retained for reference; current guidance remains in Expertise and Insights
Classification of Variations to Registration Dossiers for Drug Products (National Procedure — Russia)
Classification of changes to Russian national drug registration dossiers, with practical guidance on variation types, documentation and submission strategy.
Certification of Medicinal Products and Medical Devices in Russia
Overview of certification and declaration requirements for medicinal products and medical devices in Russia, with regulatory support from Pharegis.
Phase III Clinical Studies in Russia
Regulatory and operational support for Phase I and Phase II clinical studies in Russia, from study planning and submissions to local execution.