PSUR Central – Sierra Leone

PSUR Preparation & Review Services

Pharmacy Board of Sierra Leone (PBSL) | Ministry of Health | 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 Sierra Leone–based pharmaceutical companies, Marketing Authorization Holders (MAHs), and licensed importers supplying to the national 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 Pharmacy Board of Sierra Leone (PBSL) and the Ministry of Health, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Sierra Leone

PSUR Central works closely with:

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

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

Our PSUR Services – Sierra Leone

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per PBSL / Ministry of Health requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for PBSL 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
• PBSL 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 PBSL acceptance)

Why Companies in Sierra Leone 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 Sierra Leone’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 PBSL and global regulatory requirements.

PSUR Central

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

If you’d like, I can also:
✔ Add PBSL-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