PSUR Central – Global PSUR & PBRER Services
Supporting Africa’s Healthcare Sovereignty: SAHPRA | NAFDAC | WHO | ICH Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the pharmaceutical leaders and distributors operating across the African continent.
As African nations move toward harmonized regulatory frameworks and stricter pharmacovigilance (PV) mandates, "authority-ready" safety documentation is essential for market retention and public health. Since 2008, we have supported firms in major hubs—from Johannesburg and Lagos to Nairobi and Cairo—delivering scientifically robust reports that align with local requirements and international ICH standards.
Who We Support in Africa
We provide specialized pharmacovigilance expertise to the continent's growing pharmaceutical landscape:
Local Manufacturers: Managing safety reporting for African-produced generics and essential medicines to meet WHO Prequalification and regional standards.
Global Importers & MAHs: Localizing global safety data to comply with the specific requirements of South Africa (SAHPRA), Nigeria (NAFDAC), Egypt (EDA), and Kenya (PPB).
Regional Regulatory Consortia: Supporting companies participating in joint assessment procedures like ZAZIBONA (SADC region).
Public Health Programs: Providing aggregate safety summaries for anti-retrovirals (ARVs), anti-malarials, and vaccines distributed under national tenders.
Regulatory Affairs Departments: Drafting technical responses to health authority queries or preparing for PV inspections and audits.
Our PSUR & PBRER Services
We offer scientific excellence that matches the continent's commitment to rigorous safety monitoring:
Regional-Specific PSUR Preparation: Expert drafting of reports that comply with the distinct templates and timelines required by SAHPRA (South Africa) and NAFDAC (Nigeria).
ICH-Aligned PBRERs: High-level technical writing following ICH E2C (R2) standards for products registered in harmonizing African markets.
Benefit-Risk Evaluation: Specialized assessments for infectious disease treatments, focusing on the specific safety profile within African patient populations.
Signal Detection & Management: Identifying and validating potential safety signals from local and global data to ensure proactive risk mitigation.
Technical Gap Analysis: Auditing legacy safety documentation to ensure it meets modern African GVP (Good Pharmacovigilance Practice) guidelines.
Why Pharma Leaders in Africa Choose PSUR Central
"Scientific rigor for Africa’s evolving regulatory landscape."
Harmonization Expertise: We stay ahead of the curve with the AMA (African Medicines Agency) and regional harmonization efforts, ensuring your reports remain compliant across borders.
WHO-Standard Quality: Our reports are built to the same high standards required for WHO Prequalified products, facilitating easier entry into donor-funded markets.
Global Perspective, Local Reach: We bridge the gap between international safety standards and the practical requirements of African national health authorities.
Audit-Ready Documentation: Our track record includes a 100% acceptance rate for aggregate reports across multiple African and global jurisdictions.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
SAHPRA GVP Guidelines: For the South African market.
NAFDAC Pharmacovigilance Regulations: For the Nigerian market.
ICH E2C (R2): The global benchmark for periodic safety reporting.
WHO GVP Guidelines: For medicines and vaccines in international health programs.
Get Started: Partner With Us
To provide a tailored technical scope for your African operations, we typically require:
Product Portfolio and target countries (e.g., SADC, ECOWAS, EAC).
Approved Labeling: Local Package Inserts or global reference labeling.
Estimated Patient Exposure: Sales data or patient-years specifically for the African markets.
Summary of ICSRs: Local adverse event reports and global safety database summaries.
Submission Deadlines: Per country-specific renewal or routine cycles.
Contact PSUR Central today to ensure your safety compliance across Africa is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.