PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for the Comorian Healthcare Market: ARS | SIDS | 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 pharmaceutical companies, importers, and international health partners operating in the Union of the Comoros.
The Comoros is modernizing its pharmaceutical oversight through the National Agency for Food and Drug Control and the Ministry of Health. As of 2025, the Comoros has deepened its commitment to the African SIDS Pooled Procurement program, requiring all participants to maintain high-stringency pharmacovigilance (PV) data. Furthermore, as a member of the WHO International Regulatory Cooperation for Herbal Medicines (IRCH), the Comoros now mandates specific safety reporting for traditional and herbal-based therapeutics. Since 2008, we have supported firms in Moroni, Mutsamudu, and Fomboni in delivering dossiers that satisfy both national and international safety standards.
Who We Support in the Comoros
We provide specialized pharmacovigilance expertise across the islands' unique pharmaceutical landscape:
Pharmaceutical Importers & Wholesalers: Ensuring that medicines imported from the EU, Africa, and Asia are accompanied by "authority-ready" global safety dossiers for national registration.
SIDS Pooled Procurement Partners: Assisting manufacturers in maintaining the safety documentation required for the joint procurement secretariat, ensuring continuous supply eligibility.
Herbal & Traditional Medicine Producers: Drafting specialized safety reports following WHO IRCH guidelines for the Comoros' significant medicinal plant sector.
International Health NGOs: Providing safety data summaries for vaccines and essential medicines distributed under the "Saving Lives and Livelihoods" initiative and other public health programs.
Clinical Research Associates: Managing Pharmacovigilance (PV) Associate functions for local monitoring of vaccine uptake and specialized medical countermeasures.
Our PSUR & PBRER Services
Our scientific precision aligns with the Comorian goal of ensuring safe medicine access across all three islands:
ICH E2C (R2) Compliant PBRER Preparation: Expert drafting of benefit-risk evaluations that transition from simple data listings to comprehensive clinical justifications.
Herbal Medicine Vigilance: Specialized reporting for plant-derived health products, a 2025 priority for the Comorian regulatory authorities.
Benefit-Risk Synthesis: High-level medical evaluations that justify a product's safety profile in the context of the Comorian clinical environment and population.
Post-Market Surveillance (PMS) Support: Assisting firms in fulfilling the mandatory monitoring of adverse drug reactions (ADRs) reported to the National Pharmacovigilance Centre.
Bilingual Documentation: Providing technical safety summaries in French and English, ensuring full accessibility for Comorian regulators and international partners.
Why Pharma Leaders in the Comoros Choose PSUR Central
"Scientific rigor for the Comoros' emerging and collaborative pharmaceutical regulatory framework."
SIDS Regional Alignment: We understand the technical requirements of the African Small Island Developing States joint procurement framework, helping you maintain compliance across multiple island markets.
2025 Regulatory Specialists: Fully versed in the latest WHO PIDM and IRCH reporting standards, ensuring your traditional and modern medicine portfolios are protected.
Audit-Ready Documentation: Our reports have a 100% acceptance track record with global health organizations and regional regulatory agencies.
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:
Comoros Pharmacy Law & National Drug Policy: The legal foundation for pharmaceutical activities in the Union.
African SIDS Pooled Procurement Guiding Principles: The harmonized standards for joint medicines purchase and safety.
WHO International Regulatory Cooperation for Herbal Medicines (IRCH): The global standard for herbal product safety.
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 the Comoros, we typically require:
Product Portfolio and registration status (National or SIDS Joint Procurement).
Product Category: Modern pharmaceutical, vaccine, or traditional/herbal medicine.
Approved Labeling: The SmPC (Summary of Product Characteristics) and Patient Leaflet in French.
Local Safety Data: Summary of ADRs reported from the Comorian market or via the Dhirithi/VigiBase system.
Submission Timeline: Coordination with your registration renewal or procurement contract deadlines.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in the Comoros is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.