PSUR Central – Singapore

PSUR Preparation & Review Services

HSA Singapore | 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 Singapore-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and Product License Holders supplying to the Singapore market and regulated global destinations.

Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth Health Sciences Authority (HSA) Singapore compliance, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Singapore

PSUR Central works closely with:

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

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

Our PSUR Services – Singapore

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per HSA Singapore 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 HSA Singapore 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 HSA-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
• HSA Singapore 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 HSA acceptance)

Why Singapore Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple international markets
• Strong expertise in HSA Singapore 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 Singapore’s regulatory and ASEAN hub role

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 HSA submission timelines

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

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Singapore pharmaceutical companies, MAHs, and Product License Holders with globally acceptable pharmacovigilance documentation.

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