PSUR Central – Uzbekistan
PSUR Preparation & Review Services
Ministry of Health Uzbekistan | SCES | 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 Uzbekistan-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Uzbek 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 Republic of Uzbekistan and the State Center for Expertise and Standardization (SCES), uninterrupted product renewals, and effective post-marketing safety management.
Who We Support in Uzbekistan
PSUR Central works closely with:
• Uzbek pharmaceutical manufacturers and MAHs
• Authorized local representatives and licensed importers
• Companies importing products from EU, India, CIS, Central Asia & other regulated markets
• Firms managing post-marketing safety obligations under Uzbekistan regulations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions
Our services are designed to meet Uzbekistan regulatory expectations while fully aligning with international pharmacovigilance requirements.
Our PSUR Services – Uzbekistan
We provide complete lifecycle support for PSUR documentation, including:
• PSUR preparation as per Uzbekistan MoH / SCES requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for SCES / 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
• WHO Pharmacovigilance Guidelines
• EU GVP Module VII (where applicable)
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• Uzbekistan MoH / SCES 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 SCES acceptance)
Why Companies in Uzbekistan Choose PSUR Central
• Regulatory-focused, globally acceptable PSURs
• Templates accepted across Uzbekistan, CIS & Central Asia
• Strong expertise in Uzbek 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 Uzbekistan’s import-driven pharmaceutical system
How We Support You
To initiate PSUR preparation or review, we typically require:
• Product registration and approval details
• Approved labeling (SmPC / PIL)
• Sales and patient exposure data
• Adverse event summaries
• SCES / MoH submission timelines
Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with Uzbekistan MoH / SCES and global regulatory requirements.
PSUR Central
Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting pharmaceutical companies, MAHs, and authorized representatives in Uzbekistan with globally acceptable pharmacovigilance documentation.
If you wish, I can also:
✔ Add SCES Uzbekistan–specific PSUR FAQs
✔ Create a concise Russian–English landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for CIS / Central Asia multi-country registrations