PSUR Central – Global PSUR & PBRER Services

PSUR Central – Africa PSUR Preparation & Review Services

African MOH | WHO | ICH | PIC/S | Country-Specific Pharmacovigilance Compliant

PSUR Central, a specialized scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Periodic Safety Update Report (PSUR) Preparation and Review Services for pharmaceutical companies supplying medicines across African markets.

Since 2008, PSUR Central has supported pharmaceutical manufacturers and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable PSUR documentation, ensuring continuous pharmacovigilance compliance, smooth product lifecycle management, and effective response to African health authorities.

Our PSUR services are designed specifically for African regulatory frameworks, WHO pharmacovigilance guidance, and country-specific MOH requirements.

Who We Support Across Africa

PSUR Central works closely with:

• Pharmaceutical manufacturers exporting medicines to Africa
• Marketing Authorization Holders (MAHs) responsible for pharmacovigilance reporting
• Companies supplying to government tenders and national procurement programs
• Regulatory Affairs and Pharmacovigilance teams managing post-marketing safety obligations
• Companies preparing PSURs for renewals, variations, and routine submissions
• Organizations responding to MOH safety observations or pharmacovigilance inspections

Our services ensure alignment with African pharmacovigilance expectations while meeting international regulatory standards.

Our PSUR Services

We provide complete lifecycle support for PSUR preparation and submission, including:

• Preparation of PSUR / PBRER as per African country regulations
• Independent technical and regulatory review of existing PSURs
• MOH query handling and response preparation (post-submission)
• Gap assessment of safety data against pharmacovigilance guidelines
• Customization of PSURs based on product type and approval status
• Provision of regulator-ready PSUR templates accepted by African authorities

All PSURs are developed using a science-driven and regulatory-focused approach, ensuring clarity, consistency, and compliance with authority expectations.

Our Experience in African Markets

• 750+ PSURs prepared globally
• Active since 2008
• Experience across East Africa, West Africa, North Africa, and Southern Africa
• Coverage of innovator, generic, branded generic, and legacy pharmaceutical products
• Strong regulatory exposure with African MOHs, WHO prequalification frameworks, and PIC/S-aligned authorities
• Proven support for routine PSUR submissions, renewals, and safety variations

Regulatory Standards Followed

Our PSUR documentation aligns with:

• ICH E2C (R2) – Periodic Benefit-Risk Evaluation Report (PBRER)
• WHO Pharmacovigilance Guidelines
• African Medicines Regulatory Harmonization (AMRH) principles
• PIC/S pharmacovigilance expectations
• Country-specific Ministry of Health requirements
• Local submission formats and reporting timelines

Therapeutic Areas & Product Types Covered

• Prescription pharmaceutical medicines
• Over-the-counter (OTC) medicines
• Fixed-dose combinations (FDCs)
• Generic pharmaceutical products
• APIs (where pharmacovigilance reporting is required)
• Herbal and traditional medicines (where accepted by regulators)

Why Pharmaceutical Companies Choose PSUR Central for Africa

• Regulatory-focused, authority-ready PSUR documentation
• Templates compatible with African MOH submission systems
• Strong expertise in MOH safety query responses
• Detailed benefit-risk evaluation and safety signal analysis
• Reduced regulatory deficiencies and follow-up queries
• Confidential, professional, and deadline-driven service
• Deep understanding of African regulatory procedures and export challenges

How We Support You

To initiate PSUR preparation or review, we typically require:

• Product registration and approval details
• Approved labeling (SmPC / Package Insert)
• Sales data and patient exposure estimates
• Adverse event / safety data summaries
• Target African countries and submission timelines

Based on this information, our team will provide a customized technical scope, timelines, and commercial proposal.

PSUR Central

African Pharmacovigilance Compliance. Science-Driven. Authority-Ready.