PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Austria’s Life Science Hub: BASG | AGES | EMA | ICH
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for Austria’s world-class biopharmaceutical and medical research sectors.
Austria stands at the forefront of European innovation, from the global excellence of the Vienna BioCenter to the specialized manufacturing clusters in Kundl and Schaftenau. With the mandatory shift to the EMA IRIS platform for PSUR management as of January 2025, and the continued rigor of BASG inspections, maintaining technically flawless safety documentation is vital. Since 2008, we have supported Austrian Marketing Authorization Holders (MAHs) in delivering scientifically robust reports that clear the highest regulatory hurdles.
Who We Support in Austria
We provide specialized pharmacovigilance expertise across the Austrian pharmaceutical landscape:
Biopharmaceutical Innovators (Vienna/Tyrol): Drafting complex PBRERs for mAbs, therapeutic proteins, and nucleic acid-based therapies.
Global Generic Leaders: Managing high-volume aggregate reporting cycles for expansive portfolios exported from Austria to over 100 markets.
Specialized API & Vaccine Producers: Supporting the unique safety monitoring needs for biological active ingredients and complex vaccines.
National Specialty Pharma: Assisting Austrian-based firms in ensuring their safety dossiers meet both the Austrian Medicines Act (AMG) and EU GVP standards.
Qualified Persons for PV (QPPV) & LPPVs: Providing technical bandwidth for signal detection, medical writing, and managing the 2025 IRIS submission transition.
Our PSUR & PBRER Services
Our scientific precision matches Austria’s reputation for pharmaceutical quality and clinical excellence:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring 100% alignment with the latest EMA/BASG digital submission workflows.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data collation to provide a comprehensive, defensible clinical narrative.
Signal Detection & Registry Integration: Utilizing scientific methodologies to validate safety signals, leveraging data from EudraVigilance and local Austrian safety registries.
RMP & PSMF Alignment: Ensuring that your Periodic Safety Reports are perfectly synchronized with your Risk Management Plans and Pharmacovigilance System Master File.
Technical Gap Analysis: Pre-audit reviews of safety reports to ensure they meet the expectations of BASG/AGES pharmacovigilance inspections.
Why Pharma Leaders in Austria Choose PSUR Central
"Scientific rigor for the heart of European life sciences innovation."
2025 Regulatory Specialists: Fully prepared for the mandatory use of the IRIS platform for all lifecycle procedures, ensuring no disruption in your submission cycles.
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, BASG, and other Level IV regulatory agencies (US FDA, PMDA).
Reliability & Data Security: Professional execution with strict adherence to European data privacy standards (GDPR) and rigorous submission timelines.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Austrian Medicines Act (AMG): The legal foundation for medicine safety in Austria.
EU GVP Module VII: The mandatory European standard for Periodic Safety Update Reports.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
BASG/AGES Guidelines: Specific national requirements for pharmacovigilance and reporting.
Get Started: Partner With Us
To initiate a customized project for your Austrian-based operations, we typically require:
Product Portfolio and target markets (Austria, EU, 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 BASG 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.