PSUR Central – The Gambia

PSUR Preparation & Review Services

MCA Gambia | 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 The Gambia–based pharmaceutical companies, Marketing Authorization Holders (MAHs), and licensed importers supplying to the Gambian market and regulated international destinations.

Since 2008, PSUR Central has supported pharmaceutical companies globally with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth compliance with the Medicines Control Agency (MCA), The Gambia, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in The Gambia

PSUR Central works closely with:

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

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

Our PSUR Services – The Gambia

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per MCA Gambia 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 MCA Gambia 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
• MCA Gambia 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 MCA acceptance)

Why Companies in The Gambia Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across West Africa, ECOWAS & international markets
• Strong expertise in African health authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of The Gambia’s import-driven pharmaceutical system

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 (where applicable)
• 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 MCA Gambia and global regulatory requirements.

PSUR Central

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

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