PSUR Central – Myanmar

PSUR Preparation & Review Services

FDA Myanmar | 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 Myanmar-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and licensed importers supplying to the Myanmar market and regulated international destinations.

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

Who We Support in Myanmar

PSUR Central works closely with:

• Myanmar pharmaceutical manufacturers and MAHs
• Licensed importers, distributors, and local agents
• Companies importing products from India, ASEAN, EU, and other regulated markets
• Firms managing post-marketing safety obligations under FDA Myanmar
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

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

Our PSUR Services – Myanmar

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per FDA Myanmar and country-specific requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for FDA Myanmar 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 regulator-accepted, 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
• FDA Myanmar 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 FDA Myanmar acceptance)

Why Myanmar Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple international markets
• Strong expertise in FDA Myanmar 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 Myanmar’s import-driven pharmaceutical market

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
• Source countries and submission timelines

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

PSUR Central

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

If you want next, I can:
✔ Add FDA Myanmar-specific PSUR FAQs
✔ Shorten this into a landing-page version
✔ Convert it into a brochure or regulatory PDF
✔ Localize further for import-only registrations