PSUR Central – Armenia

PSUR Preparation & Review Services

Ministry of Health Armenia | SCDMTE | 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 Armenia-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Armenian 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 Armenia and the Scientific Centre of Drug and Medical Technology Expertise (SCDMTE), uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Armenia

PSUR Central works closely with:

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

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

Our PSUR Services – Armenia

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per Armenia MoH / SCDMTE 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 SCDMTE / 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 EAEU 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
• Armenia MoH / SCDMTE 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 Armenia Choose PSUR Central

• EAEU- and regulator-focused PSURs
• Templates accepted across Armenia, EAEU & international markets
• Strong expertise in SCDMTE 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 Armenia’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
• SCDMTE / EAEU submission timelines

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

PSUR Central

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

If you’d like, I can also:
✔ Add SCDMTE / Armenia-specific PSUR FAQs
✔ Create a concise Armenian–Russian–English landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for EAEU multi-country registrations