PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Qatar’s National Health Strategy: MOPH | PDCD | ICH | GCC
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 sectors in the State of Qatar.
Qatar is advancing toward a world-class healthcare system as part of its National Health Strategy 2024–2030. The Pharmacy and Drug Control Department (PDCD) of the MOPH has intensified its oversight of post-market safety. As of 2025, the regulatory landscape has evolved with stricter Braille labeling mandates and the full integration of the Dhirithi/PDCD online e-system. Whether you are an international manufacturer or a local agent in Doha, our dossiers ensure your products remain compliant with both Qatari national law and ICH E2C (R2) standards.
Who We Support in Qatar
We provide specialized pharmacovigilance expertise across the Qatari life sciences ecosystem:
Multinational Pharmaceutical Companies: Managing global aggregate reporting cycles for innovative therapies and biologicals registered in Qatar.
Authorized Qatari Pharmaceutical Agents: Providing the technical scientific bandwidth required by local agents to fulfill their legal obligations to the MOPH and handle safety inquiries.
Local Manufacturers & Biotech Firms: Supporting Qatar's growing domestic production base with global-standard PV systems and aggregate reporting for export markets.
Clinical Trial Sponsors: Drafting Development Safety Update Reports (DSURs) in accordance with the newly enacted Law No. (6) of 2025 Regulating Health Research.
Regulatory Affairs Departments: Managing the 2025 transition to the PDCD Online Portal for all pharmacovigilance and variation submissions.
Our PSUR & PBRER Services
Our scientific precision aligns with the MOPH’s focus on the highest standards of drug safety and quality:
eCTD-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully compliant with the Qatari eCTD Submission Guidelines for initial registration and 5-year renewals.
2025 Braille & Labeling Update Support: Assisting MAHs in updating safety sections of the SmPC and PIL to reflect new mandatory Braille information requirements effective from late 2025.
Benefit-Risk Synthesis: High-level clinical evaluations that go beyond simple data to provide a robust defense of your product's profile for the MOPH Registration Committee.
Local Signal Detection: Utilizing scientific methodologies to assess safety signals, incorporating data from the National Pharmacovigilance Program and global databases like VigiBase.
Regulatory Gap Analysis: Pre-submission reviews to ensure your safety dossiers meet the specific technical standards of the PDCD Pharmacy & Drug Control experts.
Why Pharma Leaders in Qatar Choose PSUR Central
"Scientific rigor for one of the GCC’s most innovative and quality-driven markets."
MOPH Portal Proficiency: We are fully operational within the PDCD online e-system, ensuring your safety updates and renewals are submitted without technical friction.
2025 Legal Compliance: Fully versed in Law No. (6) of 2025, ensuring your health research and safety reporting align with the latest Qatari statutes.
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 MOPH, the EMA, and the US FDA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Law No. 3 of 1983 (Regulating Pharmacology Professions): The foundational legal framework for pharmacy in Qatar.
Law No. (6) of 2025 (Regulating Health Research): Regarding the conduct and safety monitoring of clinical research.
MOPH Braille Guideline (Nov 2025): The new technical standards for medicinal product labeling.
GCC Guidelines for Good Pharmacovigilance Practices (GVP): The regional benchmark for safety reporting.
Get Started: Partner With Us
To initiate a customized project for your operations in Qatar, we typically require:
Product Portfolio and current registration status with the Pharmacy and Drug Control Department.
Local Agent Details: Information on your authorized Qatari agent for portal coordination.
Approved Labeling: The SmPC (Summary of Product Characteristics) in Arabic and English, including any recent Braille-related modifications.
Estimated Patient Exposure: Units sold or patient-years (Global and Qatar-specific).
Submission Calendar: Coordination with your 5-year registration renewal cycles or specific MOPH circulars.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.