PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Oman’s Healthcare Vision: 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 sector in the Sultanate of Oman.
Oman is a critical growth market within the GCC, driven by the Oman Vision 2040 initiative to localize pharmaceutical manufacturing and enhance drug safety. As of January 2025, the Drug Safety Center (DSC) under the Ministry of Health has issued mandatory updates regarding the appointment of safety personnel and the digital submission of aggregate reports. Since 2008, we have supported Marketing Authorization Holders (MAHs) in ensuring their safety dossiers meet the high clinical and regulatory expectations of the Oman MOH.
Who We Support in Oman
We provide specialized pharmacovigilance expertise to the key players in Oman’s pharmaceutical sector:
International Research & MNCs: Managing multi-regional PBRER cycles for innovative products registered in Oman through the GCC Centralized Procedure.
Local Safety Responsibles (LSR): Providing technical bandwidth to the mandatory Omani national LSRs (as per Circular No. 28/2019 and 13/2025) for signal detection and report drafting.
Domestic Manufacturers: Supporting Oman’s local production leaders in Muscat and Salalah with global-standard PV systems and aggregate safety reporting.
Biotech & Innovative Device Firms: Drafting safety reports for the newly regulated "Innovative Medical Devices" following the July 2025 MOH Guidelines.
Regulatory Compliance Teams: Managing the 2025 transition to the reactivated MOH e-Portal for digital pharmacovigilance report submissions.
Our PSUR & PBRER Services
Our scientific precision aligns with the MOH’s focus on the highest standards of drug safety and quality:
2025 Portal-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, optimized for submission via the reactivated Oman MOH e-Portal as per Circular No. 97/2025.
Omani LSR Technical Support: Assisting local safety officers in fulfilling their 24/7 availability and authority communication mandates with scientifically robust medical writing.
Benefit-Risk Synthesis: High-level clinical evaluations that go beyond data to justify the safety profile of medicines for the Oman Technical Committee.
Signal Detection & ADR Monitoring: Utilizing scientific methodologies to validate and assess safety signals from EudraVigilance, global data, and local Omani spontaneous reports.
Medical Device Vigilance: Specialized reporting for high-risk medical devices in compliance with the 2025 Commencement of Registration mandates.
Why Pharma Leaders in Oman Choose PSUR Central
"Scientific rigor for one of the GCC’s most transparent and quality-focused pharmaceutical markets."
2025 Regulatory Specialists: Fully operational under Circular No. 13/2025 and 97/2025, ensuring your safety personnel records and portal submissions are fully compliant.
Oman National Support: We provide the "back-end" technical excellence required by your Omani national LSR to fulfill their legal duties under the Pharmacy Practice Law.
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 Oman MOH, the EMA, and the US FDA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Sultani Decree No. 35/2015: The primary law regulating the practice of the pharmacy profession in Oman.
Ministerial Decision No. 113/2020: The executive regulations for pharmaceutical institutions.
GCC Guidelines for Good Pharmacovigilance Practices (GVP): The regional standard for safety monitoring.
Oman MOH Circular No. 13/2025: Regarding the update of QPPV and Omani national LSR data.
Get Started: Partner With Us
To initiate a customized project for your operations in Oman, we typically require:
Product Portfolio and current registration status (National or GCC Centralized).
LSR Details: Information on your Omani national Local Safety Responsible for portal registration.
Approved Labeling: The SmPC (Summary of Product Characteristics) and Reference Safety Information (RSI).
Local vs. Global Data: Summary of ICSRs from the Omani market and your global safety database.
Submission Timeline: Coordination with MOH evaluation periods (typically 30–90 days).
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.