PSUR Central – Kazakhstan

PSUR Preparation & Review Services

Ministry of Health Kazakhstan | NCEMMD | 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 Kazakhstan-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Kazakhstani 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 Kazakhstan and the National Center for Expertise of Medicines and Medical Devices (NCEMMD), uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Kazakhstan

PSUR Central works closely with:

• Kazakhstani pharmaceutical manufacturers and MAHs
• Authorized local representatives and licensed importers
• Companies registering products under EAEU procedures (Kazakhstan, Russia, Belarus, Armenia, Kyrgyzstan)
• Firms managing post-marketing safety obligations under Kazakhstan / EAEU regulations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine submissions

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

Our PSUR Services – Kazakhstan

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per Kazakhstan MoH / NCEMMD 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 NCEMMD / MoH 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
• Kazakhstan MoH / NCEMMD 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 Kazakhstan Choose PSUR Central

• EAEU- and regulator-focused PSURs
• Templates accepted across Kazakhstan, EAEU & international markets
• Strong expertise in NCEMMD 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 Kazakhstan’s EAEU-linked pharmaceutical 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
• NCEMMD / EAEU submission timelines

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

PSUR Central

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

If you’d like, I can also:
✔ Add NCEMMD / 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