PSUR Central – Malaysia

PSUR Preparation & Review Services

NPRA Malaysia | US FDA | EU | WHO | PIC/S Compliant

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 Malaysia-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and Product Registration Holders (PRHs) supplying to domestic and regulated international markets.

Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth National Pharmaceutical Regulatory Agency (NPRA) compliance, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Malaysia

PSUR Central works closely with:

• Malaysian pharmaceutical manufacturers and MAHs
• Product Registration Holders (PRHs) and local agents
• Companies exporting from Malaysia to US, EU, ASEAN, GCC, Africa & LATAM
• Firms managing post-marketing safety obligations under NPRA
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

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

Our PSUR Services – Malaysia

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per NPRA Malaysia 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 NPRA 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 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
• NPRA Malaysia 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 NPRA acceptance)

Why Malaysian Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple international markets
• Strong expertise in NPRA 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 Malaysia’s regulatory and export environment

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 submission timelines

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

PSUR Central

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

If you’d like, I can also:
✔ Add NPRA-specific PSUR FAQs
✔ Create a high-conversion landing page
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for ASEAN-only or traditional medicine products