PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for the Blue Economy’s Healthcare Future: PHA | 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 the pharmaceutical and health product sectors in the Republic of Seychelles.
Seychelles is currently refining its regulatory oversight to match its high-income status and unique geographical needs. As of 2025, the Public Health Authority (PHA) has intensified its monitoring of medicinal products, particularly following the enactment of the Hazardous Chemicals Bill 2025, which mandates stricter reporting for products with complex chemical profiles. Furthermore, through the African Small Island Developing States (SIDS) Pooled Procurement initiative, Seychelles now requires highly standardized safety data to ensure supply chain security. Since 2008, we have supported firms in Victoria and across Mahé in delivering safety dossiers that satisfy both national and international clinical review standards.
Who We Support in Seychelles
We provide specialized pharmacovigilance expertise across the islands' professional healthcare network:
Pharmaceutical Importers & Wholesalers: Managing safety documentation required by the Trade Division (Ministry of Finance) and the Ministry of Health for annual import license renewals.
Registered Private Practitioners: Providing technical safety data and signal summaries to support the reporting of adverse events to the Commissioner of Health Services.
SIDS Pooled Procurement Partners: Assisting manufacturers in maintaining the high-stringency safety dossiers needed for the joint regional procurement secretariat.
Biotech & Specialized Medicine Exporters: Drafting PBRERs for innovative therapies, vaccines, and "Named Patient" medications imported for the Seychelles National Essential Medicines List.
Retail Pharmacies & Healthcare Facilities: Assisting in the technical assessment of "Dangerous Drugs" and controlled substances under the 2025 updated safety regulations.
Our PSUR & PBRER Services
Our scientific precision aligns with the Ministry of Health’s goal of delivering quality pharmaceutical care:
ICH E2C (R2) Compliant PBRER Preparation: Expert drafting of benefit-risk evaluations that go beyond simple data listings to provide a robust clinical defense of your product's safety.
2025 "Hazardous Chemicals" Safety Alignment: Special reporting for medicinal products that fall under the new Bill 13 of 2025 classification, ensuring environmental and human health safety data is integrated.
Benefit-Risk Synthesis: High-level medical evaluations that justify the product’s safety profile within the Seychellois clinical context and small-population demographic.
Post-Market Surveillance (PMS) Support: Assisting firms in fulfilling the mandatory monitoring of adverse drug reactions (ADRs) reported to the National Pharmaceutical Services Administration.
Import License Dossier Support: Ensuring all safety sections for annual restricted-item import licenses are scientifically robust and authority-ready.
Why Pharma Leaders in Seychelles Choose PSUR Central
"Scientific rigor for the Seychelles' modern and collaborative regulatory environment."
2025 Regulatory Specialists: Fully versed in the latest Seychelles National Medicine Policy updates and the 2025 Hazardous Chemicals mandates.
SIDS Regional Alignment: We understand the requirements of the Small Island Developing States joint procurement framework, facilitating compliance across the Indian Ocean region.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
100% Acceptance Rate: Our reports have a perfect track record with global regulatory agencies, the EMA, and the US FDA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Public Health Act, 2015 (and 2025 Revised Notices): The primary legal framework for health and pharmaceutical oversight in Seychelles.
Hazardous Chemicals Bill, 2025: The new standard for the management and reporting of chemical-based health products.
Seychelles National Medicine Policy: The guiding framework for the safety, efficacy, and quality of medicines.
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 Seychelles, we typically require:
Product Portfolio and registration/import status (National or SIDS Joint Procurement).
Product Category: Information on whether the product falls under the "Restricted" or "Hazardous" lists.
Approved Labeling: The SmPC (Summary of Product Characteristics) and Patient Information Leaflet in English or French.
Local vs. Global Data: Summary of ADRs reported in the Seychelles market and your global safety database.
Submission Timeline: Coordination with your annual Import Licensing cycles or SIDS contract windows.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Seychelles is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.