PSUR Central – Vietnam

PSUR Preparation & Review Services

DAV (Vietnam MOH) | 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 Vietnam-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and product license holders supplying to the Vietnamese market and regulated international destinations.

Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth Drug Administration of Vietnam (DAV), Ministry of Health compliance, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Vietnam

PSUR Central works closely with:

• Vietnamese pharmaceutical manufacturers and MAHs
• Licensed importers, local agents, and distributors registered with DAV (MOH)
• Companies exporting from Vietnam to US, EU, ASEAN, GCC, Africa & LATAM
• Firms managing post-marketing safety obligations under Vietnam MOH
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

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

Our PSUR Services – Vietnam

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per Vietnam MOH / DAV and country-specific requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & importing country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for DAV / MOH authority queries post-submission
• Safety data gap assessment against current global PV guidelines
• Customization of PSURs based on product type, approval status, and target markets
• Supply of DAV-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
• Vietnam MOH / DAV 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)
• Traditional and herbal medicines (subject to Vietnam MOH acceptance)

Why Vietnamese Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across ASEAN and international markets
• Strong expertise in Vietnam MOH / DAV and global authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Vietnam’s regulatory and ASEAN export landscape

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
• Target countries and Vietnam MOH / DAV submission timelines

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

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Vietnamese pharmaceutical companies, MAHs, and license holders with globally acceptable pharmacovigilance documentation.

If you want next, I can:
✔ Add Vietnam MOH / DAV–specific PSUR FAQs
✔ Shorten this into a high-conversion landing page
✔ Convert it into a brochure or regulatory PDF
✔ Localize further for ASEAN-only or export-driven products