PSUR Central – Ukraine
PSUR Preparation & Review Services
Ministry of Health of Ukraine | State Expert Center (SEC) | EU GVP | US FDA | 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 Ukraine-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Ukrainian 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 Ukraine and the State Expert Center (SEC), uninterrupted product renewals, and effective post-marketing safety management.
Who We Support in Ukraine
PSUR Central works closely with:
• Ukrainian pharmaceutical manufacturers and MAHs
• Authorized local representatives and licensed importers
• Companies registering products via national and EU-aligned procedures
• Firms managing post-marketing safety obligations under Ukrainian law
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine submissions
Our services are designed to meet Ukraine regulatory expectations while fully aligning with EU and international pharmacovigilance standards.
Our PSUR Services – Ukraine
We provide complete lifecycle support for PSUR documentation, including:
• PSUR preparation as per MoH Ukraine / SEC requirements
• PSURs aligned with EU GVP Module VII, US FDA, WHO & PIC/S
• Independent technical and regulatory review of existing PSURs
• Support for SEC / MoH authority queries post-submission
• Safety data gap assessment against current EU 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
• EU GVP Module VII
• EMA PSUR Repository principles (where applicable)
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• Ukraine MoH / SEC 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 / SEC acceptance)
Why Companies in Ukraine Choose PSUR Central
• EU-aligned, regulator-focused PSURs
• Templates accepted across Ukraine, EU-linked and international markets
• Strong expertise in SEC and EU-harmonized regulatory interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Ukraine’s evolving, EU-integrated regulatory framework
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
• SEC / MoH submission timelines
Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with Ukraine MoH / SEC, EU GVP, and global regulatory requirements.
PSUR Central
Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting pharmaceutical companies, MAHs, and authorized representatives in Ukraine with EU-aligned and globally acceptable pharmacovigilance documentation.
If you want, I can next:
✔ Add SEC Ukraine–specific PSUR FAQs
✔ Create a concise Ukrainian–English landing page
✔ Convert this into a brochure or regulatory PDF
✔ Align Ukraine PSURs with EU / EMA lifecycle strategies