PSUR Central – Russia
PSUR Preparation & Review Services
Ministry of Health Russia | Roszdravnadzor | EAEU | US FDA | EU | WHO | PIC/S Aligned
PSUR Central is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Periodic Safety Update Report (PSUR) Preparation and Review Services for Russia-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Russian market and regulated international destinations.
Since 2008, PSUR Central has supported pharmaceutical companies globally with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth compliance with the Ministry of Health of the Russian Federation and Roszdravnadzor, uninterrupted product renewals, and effective post-marketing safety management.
Who We Support in Russia
PSUR Central works closely with:
• Russian pharmaceutical manufacturers and MAHs
• Authorized local representatives and licensed importers
• Companies registering products under EAEU procedures
• Firms managing post-marketing safety obligations under Russian and EAEU regulations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine submissions
Our services are designed to meet Russian regulatory expectations while fully aligning with EAEU and international pharmacovigilance requirements.
Our PSUR Services – Russia
We provide complete lifecycle support for PSUR documentation, including:
• PSUR preparation as per Russia MoH / Roszdravnadzor and EAEU requirements
• PSURs aligned with EAEU GVP, US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for Roszdravnadzor authority queries post-submission
• Safety data gap assessment against current EAEU and global PV guidelines
• Customization of PSURs based on product type, approval status, and registration pathway
• Supply of authority-acceptable, ready-to-use PSUR templates
All PSURs are science-driven, non-generic, and authority-ready.
Regulatory Standards Followed
Our PSUR documentation is prepared in alignment with:
• ICH E2C (R2) Guidelines
• EAEU Good Pharmacovigilance Practice (GVP)
• EU GVP Module VII (where applicable)
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• Russian MoH / Roszdravnadzor pharmacovigilance requirements
• Country- and EAEU-specific formats and reporting timelines
Product Types & Therapeutic Coverage
• Prescription pharmaceutical products
• Over-the-counter (OTC) medicines
• Fixed-Dose Combinations (FDCs)
• APIs (where applicable)
• Herbal and traditional medicines (subject to MoH / EAEU acceptance)
Why Companies in Russia Choose PSUR Central
• EAEU- and regulator-focused PSURs
• Templates accepted across Russia, EAEU & international markets
• Strong expertise in Roszdravnadzor and EAEU authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Russia’s EAEU-linked pharmaceutical regulatory system
How We Support You
To initiate PSUR preparation or review, we typically require:
• Product registration and EAEU procedure details
• Approved labeling (SmPC / PIL)
• Sales and patient exposure data
• Adverse event summaries
• Roszdravnadzor / EAEU submission timelines
Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with Russia MoH / Roszdravnadzor, EAEU, and global regulatory requirements.
PSUR Central
Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting pharmaceutical companies, MAHs, and authorized representatives in Russia with EAEU- and globally acceptable pharmacovigilance documentation.
If you’d like, I can also:
✔ Add Roszdravnadzor / EAEU-specific PSUR FAQs
✔ Create a concise Russian–English landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for EAEU multi-country registrations