PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for the French Life Sciences Sector: ANSM | 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 France’s elite pharmaceutical, biotech, and MedTech industries.
France is the "heart of pharma" in Europe, with a market projected to reach USD 75.7 billion by 2030. From the global headquarters of Sanofi in Paris to the high-tech bioproduction clusters in Lyon (Biopôle) and the Île-de-France region, French firms operate under some of the world’s most stringent safety regulations. Since 2008, we have supported French Marketing Authorization Holders (MAHs) and "Exploitants" in delivering scientifically robust aggregate reports that satisfy the rigorous clinical expectations of the ANSM and the EMA.
Who We Support in France
We provide specialized pharmacovigilance expertise to the core of the French pharmaceutical ecosystem:
MNC Global HQs & Large Manufacturers: Managing high-volume, multi-regional PBRER cycles for innovative and generic portfolios exported globally.
Innovative Biotechs (Paris/Lyon/Nantes): Drafting complex safety reports for biologics, vaccines, and advanced therapy medicinal products (ATMPs).
Pharmaceutical "Exploitants": Assisting French companies responsible for the actual marketing and distribution of products in ensuring local safety compliance.
Local Reference Persons (RPV): Providing technical bandwidth to the mandatory Reference Person for Pharmacovigilance (RPV) for signal detection, medical writing, and SNE (Spontaneous Notification) analysis.
MedTech & Drug-Device Innovators: Supporting the booming Île-de-France MedTech hub with safety summaries for drug-device combinations.
Our PSUR & PBRER Services
Our scientific excellence matches France’s reputation for medical precision and regulatory rigor:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully aligned with the mandatory EMA IRIS platform transition effective January 2025.
Local French Signal Detection: Utilizing scientific methodologies to validate and assess safety signals specifically for the French population, incorporating data from the 31 Regional Pharmacovigilance Centres (CRPV).
Benefit-Risk Synthesis: High-level medical evaluation that moves beyond data to provide a compelling clinical narrative for the ANSM and the PRAC.
Transition Support for "Fast-Track" Trials: Aligning Annual Safety Reports (ASRs) with France’s new 2025 Fast-Track Authorization Pathway for clinical trials.
Technical Gap Analysis: Pre-audit reviews to ensure reports meet the specific requirements of the French Public Health Code (Article R. 5121-164).
Why Pharma Leaders in France Choose PSUR Central
"Scientific rigor for Europe's most innovative and data-driven pharmaceutical market."
RPV Support Specialists: We understand the unique French requirement for a resident RPV (Doctor or Pharmacist) and provide the back-end technical writing to support their legal responsibilities.
2025 Regulatory Readiness: Fully operational on the IRIS platform, ensuring that all 2025 submission deadlines are met with technical precision.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across the ANSM, EMA, and US FDA.
High-Stringency Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
French Public Health Code (CSP): The legal foundation for pharmacovigilance and the role of the RPV and Responsible Pharmacist.
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
ANSM Good Pharmacovigilance Practices: Specific national requirements for signal management and local reporting.
Get Started: Partner With Us
To initiate a customized project for your French-based operations, we typically require:
Product Portfolio and target markets (France, EU, USA, Global).
Approved Labeling: The French SmPC (RCP) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and France-specific).
Summary of ICSRs: Line listings and tabulations from the ANSM/EudraVigilance or your safety database.
Submission Calendar: Coordination with EURD list deadlines or specific ANSM 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.