PSUR Central – Egypt

PSUR Preparation & Review Services

Egyptian Drug Authority (EDA) | 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 Egypt-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and licensed local agents supplying to the Egyptian market and regulated global destinations.

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

Who We Support in Egypt

PSUR Central works closely with:

• Egyptian pharmaceutical manufacturers and MAHs
• Licensed importers, local agents, and distributors registered with EDA
• Companies exporting from Egypt to US, EU, GCC, Africa & LATAM
• Firms managing post-marketing safety obligations under EDA regulations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

Our services are designed to meet Egyptian regulatory expectations while fully aligning with international pharmacovigilance requirements.

Our PSUR Services – Egypt

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per EDA Egypt 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 EDA 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 EDA-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
• Egyptian Drug Authority (EDA) 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 EDA acceptance)

Why Egyptian Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across Africa, MENA, EU & international markets
• Strong expertise in EDA 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 Egypt’s regulatory and export-oriented pharmaceutical landscape

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 EDA submission timelines

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

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Egyptian pharmaceutical companies, MAHs, and local agents with globally acceptable pharmacovigilance documentation.

If you’d like, I can also:
✔ Add EDA-specific PSUR FAQs
✔ Create a high-conversion landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for Africa-only or GCC-export registrations