PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Guinea’s Pharmaceutical Growth: DNPM | WAHO | ICH | WHO
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 sector in the Republic of Guinea.
Guinea is rapidly enhancing its regulatory capacity, moving from purely administrative oversight to a rigorous scientific evaluation model. As of 2025, the Direction Nationale de la Pharmacie et du Médicament (DNPM) has transitioned to the fully harmonized ECOWAS Common Technical Document (CTD) for all new registrations and renewals. This shift mandates that Marketing Authorization Holders (MAHs) provide structured, cumulative safety data to maintain their licenses. Our dossiers are designed to satisfy the DNPM’s clinical reviewers while aligning with ICH E2C (R2) global standards.
Who We Support in Guinea
We provide specialized pharmacovigilance expertise across the Guinean pharmaceutical supply chain:
International Pharmaceutical Exporters: Managing aggregate safety reporting for medicines imported into Guinea, ensuring they meet the WAHO/ECOWAS harmonized requirements.
Local Distributors & Wholesalers: Providing the technical safety documentation needed by local representatives to fulfill their legal obligations under the Guinean Pharmacy Law.
Regional West African Manufacturers: Supporting firms within the UEMOA and ECOWAS zones with harmonized PBRERs that facilitate joint regional assessments.
Public Health & Vaccine Partners: Drafting safety summaries for essential medicines and vaccines distributed through the Central Pharmacy of Guinea (PCG).
Clinical Research Organizations: Managing DSURs for clinical trials authorized by the National Ethics Committee for Health Research (CNERS).
Our PSUR & PBRER Services
Our scientific precision aligns with Guinea’s commitment to ensuring the safety and quality of all health products:
ECOWAS-Aligned PBRER Preparation: Expert drafting in the ICH E2C (R2) format, optimized for Module 5.3.6 of the Guinean CTD submission.
2025 Digital Submission Readiness: Assisting MAHs in preparing safety dossiers for the DNPM’s emerging digital portal, reflecting the 2025 WAHO regional digital strategy.
French-Language Technical Writing: While global data is in English, we provide high-level French technical summaries and safety narratives required for official DNPM evaluations.
Signal Detection & Analysis: Utilizing scientific methodologies to assess safety signals, incorporating data from the National Pharmacovigilance Centre (NPC) in Conakry and global databases.
Benefit-Risk Synthesis: Robust medical evaluations that justify the product’s safety profile specifically for the Guinean clinical context.
Why Pharma Leaders in Guinea Choose PSUR Central
"Scientific rigor to navigate Guinea’s harmonized and modernizing regulatory landscape."
WAHO Harmonization Specialists: We understand the regional requirements of the West African Medicines Regulatory Harmonization (WA-MRH) project, ensuring your compliance is consistent across West Africa.
DNPM Expertise: We track the latest 2025 circulars from the Guinean Ministry of Health, ensuring your dossier meets every local nuance.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Audit-Ready Quality: Our reports have a 100% acceptance track record across global regulatory agencies (EMA, US FDA, and African NRAs).
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Law L/2018/024/AN: Relating to Medicines, Health Products, and the Practice of the Pharmacy Profession in Guinea.
ECOWAS Harmonized Guidelines on Pharmacovigilance: The regional benchmark for safety reporting in West Africa.
WHO Good Pharmacovigilance Practices: The global standard for national regulatory authority (NRA) strengthening.
ICH E2C (R2): The international gold standard for periodic benefit-risk reporting.
Get Started: Partner With Us
To initiate a customized project for your operations in Guinea, we typically require:
Product Portfolio and current registration status (National or ECOWAS Joint Assessment).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Patient Leaflet in French.
Estimated Patient Exposure: Units sold or patient-years (Global and Guinea-specific).
Local Safety Data: Any reports collected through the NPC or your local Guinean distribution network.
Submission Timeline: Coordination with your 5-year renewal or the DNPM’s specific periodic requests.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Guinea is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.