PSUR Central – Philippines

PSUR Preparation & Review Services

FDA Philippines | 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 Philippines-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and Certificate of Product Registration (CPR) holders supplying to the domestic market and regulated global destinations.

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

Who We Support in the Philippines

PSUR Central works closely with:

• Philippine pharmaceutical manufacturers and MAHs
• CPR holders, importers, distributors, and local agents
• Companies exporting from the Philippines to US, EU, ASEAN, GCC, Africa & LATAM
• Firms managing post-marketing safety obligations under FDA Philippines
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

Our services are designed to meet Philippine regulatory expectations while fully aligning with international pharmacovigilance standards.

Our PSUR Services – Philippines

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per FDA Philippines 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 FDA Philippines 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
• FDA Philippines post-marketing surveillance 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 Philippines acceptance)

Why Philippine Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple international markets
• Strong expertise in FDA Philippines 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 Philippines regulatory and ASEAN export requirements

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 FDA Philippines and global regulatory requirements.

PSUR Central

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

If you want next, I can:
✔ Add FDA Philippines-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-focused products