PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Germany’s Life Science Powerhouse: BfArM | PEI | 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 Germany’s world-class pharmaceutical and biotechnology sectors.
Germany is the largest exporter of medicinal products in Europe, with a manufacturing volume reaching €37.4 billion. From the global innovation hubs in Bonn and Berlin to the specialized biotech clusters in Munich, Heidelberg, and Mainz, German firms operate under the highest safety standards. Since 2008, we have supported German Marketing Authorization Holders (MAHs) in ensuring their global safety profiles remain authority-ready for BfArM and the PEI.
Who We Support in Germany
We provide specialized pharmacovigilance expertise across the German pharmaceutical landscape:
Global Research Leaders: Supporting Germany's top-tier exporters in Ludwigshafen, Ingelheim, and Leverkusen with complex, multi-national aggregate reporting.
Vaccine & Biomedicine Innovators: Drafting PBRERs for products regulated by the Paul-Ehrlich-Institut (PEI), including vaccines, blood products, and advanced therapies (ATMPs).
Mittelstand & Generic Champions: Managing safety reporting for Germany's robust medium-sized pharmaceutical sector and large-scale generic portfolios.
Stufenplanbeauftragte (Graduated Plan Officers): Providing technical bandwidth to the legally mandated German Graduated Plan Officer for signal detection and medical writing.
Regulatory Teams facing eCTD 8.2 Updates: Ensuring all submissions comply with the new December 2025 validation criteria for electronic dossiers.
Our PSUR & PBRER Services
Our scientific precision matches Germany’s reputation for pharmaceutical quality and clinical excellence:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully integrated with the new EMA IRIS digital submission workflows mandatory as of January 2025.
Local Signal Detection (BfArM/PEI): Utilizing scientific methodologies to validate and assess safety signals, incorporating data from EudraVigilance and German-specific spontaneous reporting.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data to provide a compelling clinical narrative for the PRAC and German federal authorities.
Transition Support for RMPs: Synchronizing Periodic Safety Reports with updated Risk Management Plans (RMP Rev. 3) as per the latest EU guidelines.
Technical Gap Analysis: Pre-audit reviews to ensure reports meet the specific requirements of the German Medicines Act (AMG) and GVP standards.
Why Pharma Leaders in Germany Choose PSUR Central
"Scientific rigor for Europe's largest and most innovative pharmaceutical market."
Dual-Authority Expertise: We understand the distinct requirements of the BfArM (for most medicines) and the PEI (for biologics and vaccines).
2025 Regulatory Readiness: Fully operational on the IRIS platform, ensuring that all 2025 submission deadlines are met with technical precision.
Compliance with Section 63a AMG: We provide the scientific documentation required by the Stufenplanbeauftragter to fulfill their personal legal responsibility for drug safety.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across the EMA, BfArM, PEI, and US FDA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
German Medicines Act (AMG): Particularly Sections 63a regarding the Graduated Plan Officer.
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
BfArM/PEI Bulletin on Drug Safety: Keeping pace with the quarterly safety updates issued by German federal institutes.
Get Started: Partner With Us
To initiate a customized project for your German-based operations, we typically require:
Product Portfolio and target markets (Germany, EU, USA, Global).
Approved Labeling: The German SmPC (Fachinformation) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and Germany-specific).
Summary of ICSRs: Line listings and tabulations from your safety database, EudraVigilance, or BfArM/PEI.
Submission Calendar: Coordination with EURD list deadlines or specific national 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.