PSUR Central – Hong Kong
PSUR Preparation & Review Services
Hong Kong DH | 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 Hong Kong–based pharmaceutical companies, Marketing Authorization Holders (MAHs), and product license holders supplying to regulated global markets.
Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth Department of Health (DH), Hong Kong compliance, uninterrupted renewals, and effective post-marketing safety management.
Who We Support in Hong Kong
PSUR Central works closely with:
• Hong Kong pharmaceutical companies and MAHs
• Importers, distributors, and local agents holding DH product registrations
• Companies exporting or distributing products to Mainland China, ASEAN, GCC, Africa & LATAM
• Firms managing post-marketing safety obligations under Hong Kong DH
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions
Our services are aligned with Hong Kong pharmacovigilance expectations while fully meeting international regulatory standards.
Our PSUR Services – Hong Kong
We provide complete lifecycle support for PSUR documentation, including:
• PSUR preparation as per Hong Kong DH 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 Hong Kong DH / 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 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
• Hong Kong DH 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 Hong Kong DH acceptance)
Why Hong Kong Companies Choose PSUR Central
• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple international markets
• Strong expertise in Hong Kong DH and global authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, and deadline-driven execution
• Deep understanding of Hong Kong import-export and compliance frameworks
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 Hong Kong DH and global requirements.
PSUR Central
Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Hong Kong pharmaceutical companies, MAHs, and importers with globally acceptable pharmacovigilance documentation.
If you’d like, I can next:
✔ Create a Hong Kong DH–specific FAQ section
✔ Shorten this for a landing page or homepage
✔ Convert it into a brochure or regulatory PDF
✔ Localize further for import-only or distributor-based MAHs