PSUR Central – Syria
PSUR Preparation & Review Services
Syrian MoH | 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 Syria-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and licensed importers supplying to the Syrian market and regulated international destinations.
Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth Syrian Ministry of Health (MoH) compliance, uninterrupted product renewals, and effective post-marketing safety management.
Who We Support in Syria
PSUR Central works closely with:
• Syrian pharmaceutical manufacturers and MAHs
• Licensed importers, local agents, and distributors registered with Syrian MoH
• Companies sourcing products from India, EU, ASEAN, MENA & other regulated markets
• Firms managing post-marketing safety obligations under Syrian MoH
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions
Our services are designed to meet Syrian regulatory requirements while fully aligning with international pharmacovigilance expectations.
Our PSUR Services – Syria
We provide complete lifecycle support for PSUR documentation, including:
• PSUR preparation as per Syrian MoH and country-specific requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for Syrian MoH authority queries post-submission
• Safety data gap assessment against current global PV guidelines
• Customization of PSURs based on product type, approval status, and source markets
• Supply of authority-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
• Syrian MoH 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 Syrian MoH acceptance)
Why Syrian Companies Choose PSUR Central
• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple international markets
• Strong expertise in Middle East MOHs 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 Syria’s regulatory and import-driven pharmaceutical 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
• Source countries and submission timelines
Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with Syrian MoH and global regulatory requirements.
PSUR Central
Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Syrian pharmaceutical companies, MAHs, and importers with globally acceptable pharmacovigilance documentation.
If you want, I can next:
✔ Add Syrian MoH–specific PSUR FAQs
✔ Create a short landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for import-only or humanitarian-supply registrations