PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Rwanda’s Vision 2050: Rwanda FDA | EAC | ICH | GVP
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, biotech, and medical device sectors in the Republic of Rwanda.
Rwanda is positioning itself as a regional leader in healthcare innovation and regulatory excellence. On September 18, 2025, the government enacted Law No. 026/2025 (the Rwanda Healthcare Law), a landmark statute that consolidates and modernizes the nation's healthcare legal framework. This new law, alongside the Rwanda FDA’s 2025 mandates for serialization and barcoding, requires Marketing Authorization Holders (MAHs) to maintain unprecedented levels of data transparency and safety monitoring. Our services ensure your dossiers are fully compliant with both the latest national laws and the harmonized East African Community (EAC) standards.
Who We Support in Rwanda
We provide specialized pharmacovigilance expertise across Rwanda’s high-growth healthcare sectors:
International Pharmaceutical Exporters: Managing aggregate safety reporting for medicines entering Rwanda via the EAC Joint Assessment or Abbreviated Procedures.
Domestic Manufacturers: Supporting Rwanda’s expanding local pharmaceutical production with the implementation of GVP-compliant systems and automated reporting.
Local Technical Representatives (LTR): Providing the technical scientific back-end needed by Rwanda-based agents to manage the PRIMS portal and authority queries.
Biotech & Vaccine Innovators: Drafting complex PBRERs for products handled by the BioNTech mRNA facility and other high-tech clinical ventures in Kigali.
Clinical Trial Sponsors: Managing Development Safety Update Reports (DSURs) for studies conducted under the oversight of the Rwanda National Ethics Committee (RNEC).
Our PSUR & PBRER Services
Our scientific precision aligns with the Rwanda FDA’s "Smart Pharmacovigilance" strategy and its drive toward WHO Maturity Level 3/4:
2025 Serialization-Ready Reporting: Assisting MAHs in integrating traceability data (GTIN, Batch, Serial Number) into post-market safety assessments as required by the 2025 Barcoding Mandate.
eCTD & PRIMS Submission Excellence: Expert drafting in the ICH E2C (R2) format, optimized for the Pharmaceutical Regulatory Information Management System (PRIMS).
Benefit-Risk Synthesis: High-level medical evaluations that justify the product’s safety profile within the Rwandan clinical context, a key requirement for the 2025 Health Reform Law.
Signal Detection & Analysis: Utilizing scientific methodologies to assess safety signals reported through the National Pharmacovigilance Centre and global platforms like VigiBase.
French & English Bilingual Support: Professional preparation of technical documentation in both of Rwanda’s primary regulatory languages.
Why Pharma Leaders in Rwanda Choose PSUR Central
"Scientific rigor to power Rwanda’s digital and harmonized pharmaceutical future."
2025 Law Specialists: We are fully operational under the new Law No. 026/2025, ensuring your safety duties align with the latest "Healthcare Law" consolidation.
EAC & AMRH Integration: Our reports are designed for the African Medicines Regulatory Harmonization (AMRH) framework, facilitating faster approval across the continent.
Traceability Integration: We bridge the gap between supply chain serialization and pharmacovigilance, providing a holistic view of product safety.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Law No. 026/2025 (Rwanda Healthcare Law): The comprehensive 2025 statute governing healthcare and medical products.
Rwanda FDA Regulation N° CBD/TRG/010: Governing the registration of human medicinal products.
EAC Harmonized Guidelines on Pharmacovigilance: The regional benchmark for safety monitoring in East Africa.
WHO Global Benchmarking Tool (GBT): Ensuring your safety data supports the Rwanda FDA’s path to high-stringency status.
Get Started: Partner With Us
To initiate a customized project for your operations in Rwanda, we typically require:
Product Portfolio and registration status (National, EAC Joint, or Abbreviated).
Local Agent Details: Coordination information for your registered Local Technical Representative.
Approved Labeling: The SmPC and Patient Leaflet (PIL) in English and/or French.
Local Safety Data: Summary of ICSRs reported via the Rwanda FDA reporting form or the PRIMS portal.
Submission Timeline: Coordination with your 5-year renewal or 90-day pre-expiry windows.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Rwanda is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.