PSUR Central – Belarus

PSUR Preparation & Review Services

Ministry of Health – Republic of Belarus | National Pharmacovigilance System | 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 Belarus-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Belarusian market and regulated international destinations.

Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth compliance with the Ministry of Health of the Republic of Belarus, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Belarus

PSUR Central works closely with:

• Belarusian pharmaceutical manufacturers and MAHs
• Authorized local representatives and licensed importers
• Companies importing products from EU, India, CIS, Eurasian & other regulated markets
• Firms managing post-marketing safety obligations under Belarus MoH regulations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

Our services are designed to meet Belarus regulatory expectations while fully aligning with international pharmacovigilance requirements.

Our PSUR Services – Belarus

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per Belarus Ministry of Health requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for MoH authority queries post-submission
• Safety data gap assessment against current global PV guidelines
• Customization of PSURs based on product type, approval status, and source markets
• 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
• EU GVP Module VII
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• Belarus Ministry of Health pharmacovigilance requirements
• Country-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 acceptance)

Why Companies in Belarus Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across Belarus, CIS & Eurasian markets
• Strong expertise in Belarus MoH and regional authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Belarus’s import- and export-oriented pharmaceutical system

How We Support You

To initiate PSUR preparation or review, we typically require:

• Product registration and approval details
• Approved labeling (SmPC / PI)
• Sales and patient exposure data
• Adverse event summaries
• Source countries and Belarus MoH submission timelines

Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with Belarus MoH and global regulatory requirements.

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting pharmaceutical companies, MAHs, and authorized representatives in Belarus with globally acceptable pharmacovigilance documentation.

If you’d like, I can next:
✔ Add Belarus MoH–specific PSUR FAQs
✔ Create a concise Russian–English landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for CIS / EAEU-linked registrations