PSUR Central – Ethiopia

PSUR Preparation & Review Services

EFDA Ethiopia | EPHI | 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 Ethiopia-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and licensed importers supplying to the Ethiopian market and regulated international destinations.

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

Who We Support in Ethiopia

PSUR Central works closely with:

• Ethiopian pharmaceutical manufacturers and MAHs
• Licensed importers, local agents, and distributors registered with EFDA
• Companies sourcing products from EU, India, MENA, ASEAN & other regulated markets
• Firms managing post-marketing safety obligations under EFDA regulations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

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

Our PSUR Services – Ethiopia

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per EFDA Ethiopia 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 EFDA 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 EFDA-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
• EFDA Ethiopia 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 EFDA acceptance)

Why Ethiopian Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across Africa, MENA & international markets
• Strong expertise in EFDA 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 Ethiopia’s 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 EFDA submission timelines

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

PSUR Central

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

If you want next, I can:
✔ Add EFDA-specific PSUR FAQs
✔ Create a concise landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for East Africa regional registrations