PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Brunei’s Life Sciences Sector: BDMCA | ASEAN | 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 biotechnology sector in Brunei Darussalam.
Brunei maintains a high-stringency regulatory environment, with the Brunei Darussalam Medicines Control Authority (BDMCA) overseeing drug safety under the Medicines Order 2007. As a key player in the ASEAN region, Brunei follows the ASEAN Common Technical Dossier (ACTD) standards while moving toward advanced pharmacovigilance (PV) integration. In 2025, with increasing global emphasis on structured benefit-risk evaluations, ensuring your products meet the scientific expectations of the Department of Pharmaceutical Services is essential for sustained market access.
Who We Support in Brunei
We provide specialized pharmacovigilance expertise across the Bruneian healthcare landscape:
International Pharmaceutical Exporters: Managing global aggregate reporting cycles for multi-national firms supplying the Bruneian market with NCEs (New Chemical Entities) and biologicals.
Local Licensed Importers & Wholesalers: Providing technical safety documentation (PSURs/PBRERs) required for product license renewals and post-market surveillance.
ASEAN Regional Distributors: Drafting safety reports that comply with both Brunei’s national requirements and broader ASEAN Harmonization standards.
Clinical Trial Sponsors: Preparing Development Safety Update Reports (DSURs) for clinical investigations conducted under BDMCA oversight.
Product License Holders (MAHs): Assisting with safety signal assessment and reporting to the National Adverse Drug Monitoring Centre.
Our PSUR & PBRER Services
Our scientific precision aligns with Brunei's commitment to high-quality healthcare and patient safety:
ICH E2C (R2) Compliant PBRER Preparation: Expert drafting of reports that transition from simple safety listings to comprehensive Benefit-Risk Evaluations, as expected by modern regulatory bodies.
ASEAN-Aligned Documentation: Ensuring that all aggregate reports are formatted to integrate seamlessly with ACTD submissions for the BDMCA.
Local Signal Detection & Assessment: Utilizing scientific methodologies to validate and assess safety signals, incorporating data from spontaneous reports and local medical feedback.
Benefit-Risk Synthesis: High-level clinical evaluations that provide a robust defense of your product's profile, especially for products on the Ministry of Health’s procurement lists.
Technical Gap Analysis: Pre-submission reviews of safety dossiers to ensure they meet the specific requirements of the Brunei Darussalam Pharmacovigilance Guidelines.
Why Pharma Leaders in Brunei Choose PSUR Central
"Scientific rigor for the Sultanate’s high-standard pharmaceutical market."
BDMCA-Ready Submissions: We understand the nuances of the Medicines Order 2007 and ensure all reports are ready for scrutiny by the Product Regulation Section.
Global Expertise, Regional Context: We bridge the gap between international ICH standards and the specific reporting cycles required within the ASEAN region.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across global regulatory agencies, including the EMA, US FDA, and ASEAN member states.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Brunei Medicines Order 2007: The legal foundation for all medicinal product regulation in the Sultanate.
Brunei Darussalam Pharmacovigilance Guidelines: The national standard for safety reporting and signal management.
ASEAN Common Technical Requirements (ACTR): The harmonized standards for pharmaceutical registration in the region.
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 Brunei, we typically require:
Product Portfolio and current BDMCA registration status.
Approved Labeling: The SmPC (Summary of Product Characteristics) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and Brunei-specific).
Summary of ICSRs: Line listings and tabulations from your global safety database or local reports.
Submission Calendar: Coordination with your product license renewal dates (typically every 5 years) or specific BDMCA requests.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.