PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Belgium’s Biopharma Valley: FAMHP | EMA | 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 Belgium’s world-leading pharmaceutical and biotechnology sectors.
Belgium is a global powerhouse for drug development and manufacturing, accounting for a significant portion of Europe's biopharma exports. With the FAMHP enforcing the mandatory use of the EMA IRIS platform for PSUR management as of January 2025, and the Belgian pharmaceutical market projected to reach USD 8.40 billion in 2025, the need for precision-engineered safety reporting is paramount. Since 2008, we have supported Belgian Marketing Authorization Holders (MAHs) in ensuring their global safety profiles remain authority-ready.
Who We Support in Belgium
We provide specialized pharmacovigilance expertise across the three Belgian regions:
Biotech Innovators in Flanders (Ghent/Antwerp/Leuven): Drafting complex PBRERs for advanced therapies (ATMPs), vaccines, and monoclonal antibodies.
Manufacturing Hubs in Wallonia (Gosselies/Braine-l'Alleud): Supporting large-scale manufacturers with aggregate reporting for diverse export portfolios.
MNC Regional HQs in Brussels: Managing multi-region safety reporting and coordinating with the Belgian Centre for Pharmacovigilance (BCPH).
Local Contact Persons for PV (LCPPV): Providing technical support to Belgium-resident contact persons who must be available 24/7 and proficient in national languages (French, Dutch, or German).
Parallel Distributors & Generic Firms: Ensuring compliance with the New Royal Decree (December 2025) regarding parallel distribution and periodic safety updates.
Our PSUR & PBRER Services
Our scientific excellence matches Belgium’s reputation for pharmaceutical R&D and clinical trial leadership:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully integrated with the new EMA IRIS digital submission workflows.
Local Signal Detection & Literature Monitoring: Utilizing scientific methodologies to monitor and validate safety signals from EudraVigilance, global databases, and Belgian medical literature.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data to provide a compelling clinical narrative for the PRAC and FAMHP.
Transition Support for Clinical Trials: Aligning Annual Safety Reports (ASRs) with the Clinical Trial Regulation (EU) 536/2014, mandatory for all trials as of January 2025.
Technical Gap Analysis: Pre-audit reviews of safety reports to ensure they meet the expectations of FAMHP GVP inspections.
Why Pharma Leaders in Belgium Choose PSUR Central
"Scientific rigor for Europe's most innovative biopharmaceutical ecosystem."
IRIS Implementation Experts: We are fully operational on the EMA IRIS platform, ensuring your 2025 submission cycles are managed without technical delays.
Multilingual Compliance Support: We understand the nuances of the Belgian market, including the requirement for local contact persons with national language skills.
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 the EMA, FAMHP, and other Level IV regulatory agencies (US FDA, PMDA).
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
Royal Decree of 14 December 2006: The legal foundation for pharmacovigilance in Belgium.
FAMHP Circular 601: Guidelines for local contact persons and safety reporting.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
Get Started: Partner With Us
To initiate a customized project for your Belgian-based operations, we typically require:
Product Portfolio and target markets (Belgium, EU, USA, Global).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and EEA-specific).
Summary of ICSRs: Line listings and tabulations from your safety database or EudraVigilance.
Submission Calendar: Coordination with EURD list deadlines or specific FAMHP renewal cycles.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.