PSUR Central – Burkina Faso

PSUR Preparation & Review Services

Ministry of Health Burkina Faso | ANRP | 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 Burkina Faso–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 Ministry of Health, Burkina Faso and the National Pharmaceutical Regulatory Agency (ANRP), uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Burkina Faso

PSUR Central works closely with:

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

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

Our PSUR Services – Burkina Faso

We provide complete lifecycle support for PSUR documentation, including:

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

Why Companies in Burkina Faso 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 Burkina Faso’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
• 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 Burkina Faso MoH / ANRP and global regulatory requirements.

PSUR Central

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

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