PSUR Central – Saudi Arabia

PSUR Preparation & Review Services

SFDA | 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 Saudi Arabia–based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and local license holders supplying to the Kingdom and regulated global markets.

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

Who We Support in Saudi Arabia

PSUR Central works closely with:

• Saudi pharmaceutical manufacturers and MAHs
• Local agents, distributors, and license holders registered with SFDA
• Companies exporting from or supplying to Saudi Arabia from US, EU, India, ASEAN & GCC
• Firms managing SFDA post-marketing safety obligations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine submissions

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

Our PSUR Services – Saudi Arabia

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per SFDA 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 SFDA 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 SFDA-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
• SFDA pharmacovigilance and post-marketing 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 SFDA acceptance)

Why Saudi Companies Choose PSUR Central

• Regulatory-focused, SFDA-aligned PSURs
• Templates accepted across GCC and global markets
• Strong expertise in SFDA and international authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Saudi Arabia’s regulatory and import-export framework

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 SFDA submission timelines

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

PSUR Central

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

If you’d like next, I can:
✔ Add SFDA-specific PSUR FAQs
✔ Shorten this for a landing page or homepage
✔ Convert it into a brochure or regulatory PDF
✔ Localize further for GCC-only or tender-based registrations