PSUR Central – Global PSUR & PBRER Services
Elite Compliance for the Dutch Life Sciences Corridor: CBG-MEB | 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 the Netherlands’ highly concentrated pharmaceutical and biotech ecosystem.
The Netherlands is a global leader in biopharmaceutical innovation, with nearly 2,000 companies and research organizations clustered within the Leiden-Amsterdam-Utrecht corridor. In 2025, the Dutch market is characterized by rapid digital transformation, including the mandatory adoption of the EMA IRIS platform for PSUR management and stricter oversight from the Medicines Evaluation Board (CBG-MEB). Since 2008, we have supported Dutch Marketing Authorization Holders (MAHs) in delivering aggregate reports that meet the rigorous scientific expectations of the EMA and CBG-MEB.
Who We Support in the Netherlands
We provide specialized pharmacovigilance expertise to the core of the Dutch "Life Sciences & Health" sector:
Global Biotech Pioneers (Leiden Bio Science Park): Drafting complex PBRERs for advanced therapies (ATMPs), gene therapies, and oncology breakthrough medicines.
MNC Regional HQs (Amsterdam/Utrecht): Supporting global leaders who leverage the Netherlands as their European regulatory gateway due to the EMA’s proximity.
Generic & Biosimilar Leaders: Managing safety reporting for portfolios where generic pharmaceuticals account for over 80% of reimbursed volumes in the Netherlands.
Local Safety Officers & QPPVs: Providing technical bandwidth for signal detection, medical writing, and managing IRIS portal submissions.
Innovative SMEs & Startups: Assisting firms emerging from academic clusters in Groningen and Eindhoven with their first post-market safety dossiers.
Our PSUR & PBRER Services
Our scientific precision matches the Dutch reputation for transparency, efficiency, and clinical excellence:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring 100% compliance with the new EMA IRIS digital submission workflows effective January 2025.
Signal Management & Lareb Integration: Utilizing scientific methodologies to validate safety signals, incorporating data from the Netherlands Pharmacovigilance Centre Lareb and EudraVigilance.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data collation to provide a robust clinical defense of your product’s profile.
RMP & PASS Coordination: Synchronizing Periodic Safety Reports with Risk Management Plans and Post-Authorisation Safety Studies, as mandated by updated 2025 GVP modules.
Technical Gap Analysis: Pre-audit reviews to ensure safety reports meet the expectations of IGJ (Health and Youth Care Inspectorate) and CBG-MEB inspections.
Why Pharma Leaders in the Netherlands Choose PSUR Central
"Scientific rigor for Europe's most connected and innovative life sciences hub."
Digital Transformation Specialists: We are fully operational on the IRIS platform, ensuring that your 2025 submission cycles are managed without technical delays or administrative friction.
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, CBG-MEB, and other Level IV regulatory agencies (US FDA, PMDA).
Compliance with New 2025 Standards: We integrate the latest requirements for masking personal data in ICSRs (GVP VI Addendum II) and updated RMP transparency standards.
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.
Dutch Medicines Act (Geneesmiddelenwet): The legal foundation for pharmacovigilance in the Netherlands.
CBG-MEB Policy Documents: Including the 2025 updates on risk minimisation measures (MEB 45).
ICH E2C (R2): The global benchmark for PBRER/PSUR.
Get Started: Partner With Us
To initiate a customized project for your Netherlands-based operations, we typically require:
Product Portfolio and target markets (Netherlands, EU, USA, Global).
Approved Labeling: The SmPC (Samenvatting van de Productkenmerken) 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 Lareb, your safety database, or EudraVigilance.
Submission Calendar: Coordination with EURD list deadlines or specific CBG-MEB 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.