PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Kuwait’s Healthcare Sector: MOH | GCC | ICH | US FDA
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 biotech industries in the State of Kuwait.
Kuwait boasts one of the highest per capita pharmaceutical expenditures in the GCC, with a market characterized by high-stringency oversight from the Drug and Food Control Administration. As of December 2025, the regulatory landscape has been fundamentally reshaped by Decree-Law No. 159/2025, which unifies drug control frameworks and mandates strict digital tracking for controlled substances. Since 2008, we have supported Marketing Authorization Holders (MAHs) and their Local Agents in delivering safety dossiers that satisfy the clinical and technical expectations of the Kuwaiti Ministry of Health.
Who We Support in Kuwait
We provide specialized pharmacovigilance expertise across Kuwait’s healthcare ecosystem:
Global Research & MNCs: Managing multi-regional PBRER cycles for innovative medicines registered in Kuwait through the Centralized GCC Procedure or national routes.
Local Pharmaceutical Agents: Providing the technical safety documentation required by Kuwaiti "Local Agents" to maintain product licenses and manage MOH queries.
Domestic Manufacturers (e.g., Safa Pharma): Supporting Kuwait's local production base with PV system development and aggregate reporting for domestic and export markets.
Specialized Biotech & Biosimilar Firms: Drafting complex safety reports for high-tech therapeutics that must satisfy both GCC and WHO standards.
Authorized Local Representatives: Ensuring that global safety data is localized to reflect the Kuwaiti patient population, as required by the Pharmacovigilance Office.
Our PSUR & PBRER Services
Our scientific precision aligns with Kuwait’s "Vision 2035" for a world-class healthcare infrastructure:
GCC-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring 100% alignment with the Gulf Health Council (GHC) pharmacovigilance guidelines.
2025 Digital Compliance: Assisting in the transition to mandatory electronic recording and reporting of safety data as required by the new 2025 Anti-Drug Law (Decree-Law 159/2025).
Signal Detection & RNF Integration: Utilizing scientific methodologies to assess safety signals, incorporating local spontaneous reports and global data from EudraVigilance.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data to provide a robust clinical defense of a product's safety profile for MOH technical committees.
Pharmacovigilance Master File (PSMF) Support: Assisting MAHs in maintaining a compliant PSMF, a mandatory requirement for registration in Kuwait.
Why Pharma Leaders in Kuwait Choose PSUR Central
"Scientific rigor for one of the GCC’s most demanding and quality-focused markets."
MOH Specialist Expertise: We understand the nuances of Ministerial Decision No. 382/2023 and ensure all reports are ready for the specialized Pharmacovigilance Office.
2025 Law Readiness: Fully versed in the implications of the December 2025 Anti-Drug Law, ensuring your controlled substance reporting is flawless.
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 the MOH, the EMA, and the US FDA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Kuwait Ministerial Decision No. 382/2023: The specific decree establishing the Pharmacovigilance Office.
Decree-Law No. 159/2025 (Anti-Drug Law): Regarding the regulation and safety tracking of narcotics and psychotropics.
GCC Guidelines for Good Pharmacovigilance Practices (GVP): The regional standard for safety monitoring.
ICH E2C (R2): The international gold standard for periodic benefit-risk reporting.
Get Started: Partner With Us
To initiate a customized project for your Kuwait-based operations, we typically require:
Product Portfolio and current registration status (National or GCC).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and Kuwait-specific).
Summary of ICSRs: Line listings and tabulations from the MOH database or your global safety database.
Submission Calendar: Coordination with your 5-year registration renewal cycles or specific MOH requests.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.