PSUR Central – Global PSUR & PBRER Services
Elite Compliance for the UAE’s New Era: EDE | MoHAP | GCC | ICH
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the UAE's rapidly transforming pharmaceutical and medical device sector.
The UAE is solidifying its position as a global pharmaceutical hub with the enactment of Federal Decree-Law No. 38/2024, which came into effect on January 2, 2025. This landmark legislation establishes the Emirates Drug Establishment (EDE) as the central authority for all medical products, replacing MoHAP’s regulatory functions. With 2025 marking a mandatory shift to eCTD-only submissions and the integration of Tatmeen for end-to-end traceability, our services ensure that your safety dossiers remain "authority-ready" during this critical one-year grace period.
Who We Support in the UAE
We provide specialized pharmacovigilance expertise across the Emirates' healthcare ecosystem:
Multinational Research & Innovation Firms: Managing global aggregate reporting for innovative therapies, including those under the new 2025 Fast-Track Pathway for breakthrough medicines.
Local Safety Responsibles (LSR) & QPPVs: Providing technical writing and signal detection bandwidth to meet the UAE's strict residency requirements for safety officers.
Biotechnology & Biopharmaceutical Leaders: Drafting complex PBRERs for vaccines, monoclonal antibodies, and blood derivatives, now under expanded EDE oversight.
Medical Device Manufacturers: Complying with the 2025 updated vigilance requirements for high-risk and active implantable devices.
Authorized Local Agents: Supporting licensed representatives in Dubai, Abu Dhabi, and Sharjah with the technical data needed for the EDE Online Portal and product renewals.
Our PSUR & PBRER Services
Our scientific precision aligns with the UAE’s "Zero Government Bureaucracy" vision and digital health strategy:
eCTD-Mandated PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully optimized for the mandatory eCTD submission process effective as of 2025.
EDE-Ready Safety Reporting: Navigating the transition from MoHAP to EDE guidelines, ensuring all aggregate reports meet the new "lifecycle management" standards.
2025 AI-Integrated Signal Detection: Utilizing advanced methodologies to validate safety signals, incorporating data from the national Pharmacovigilance Program and global databases.
Benefit-Risk Synthesis: High-level clinical evaluations that provide a robust defense of your product's safety profile for the EDE Technical Committees.
Risk Management Plan (RMP) Support: Developing and updating RMPs to reflect the UAE's stricter 2025 monitoring and reporting obligations.
Why Pharma Leaders in the UAE Choose PSUR Central
"Scientific rigor for a globally trusted and digitally advanced pharmaceutical market."
Federal Decree-Law No. 38/2024 Specialists: We are fully operational under the new law, assisting MAHs in consolidating regulatory, vigilance, and quality roles under one designated establishment.
eCTD & EDE Portal Proficiency: We eliminate technical friction by ensuring your dossiers are perfectly formatted for the UAE's modern digital infrastructure.
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 EDE/MoHAP, the EMA, and the US FDA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Federal Decree-Law No. 38/2024: The new governing law for pharmaceutical products and establishments in the UAE.
UAE Good Pharmacovigilance Practice (GVP) Guidelines: The national standard for safety monitoring and reporting.
GCC GVP Guidelines: The regional harmonized standards for pharmacovigilance.
ICH E2C (R2): The global benchmark for periodic benefit-risk reporting.
Get Started: Partner With Us
To initiate a customized project for your UAE-based operations, we typically require:
Product Portfolio and registration status (National, GCC, or Fast-Track).
Designated Establishment Details: Information on your primary UAE pharmaceutical establishment for regulatory and vigilance coordination.
Approved Labeling: The SmPC/PIL in Arabic and English, including Tatmeen 2-D matrix barcode details.
Local vs. Global Data: Summary of ICSRs from the UAE market and your global safety database.
Submission Calendar: Coordination with your 5-year renewal or EDE-specific monitoring cycles.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.