PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Italy’s Life Science Leaders: AIFA | 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 Italy’s high-caliber pharmaceutical and biotechnology industries.
Italy is Europe’s top pharmaceutical producer by value, with a sector fueled by high-tech manufacturing in Milan, Rome, and Florence. As of 2025, with the full implementation of the EU Clinical Trial Regulation (CTR) and the mandatory use of the EMA IRIS platform, Italian Marketing Authorization Holders (MAHs) face an increasingly digitized and stringent regulatory environment. Since 2008, we have supported Italian firms in ensuring their safety dossiers meet the rigorous expectations of AIFA and the EMA.
Who We Support in Italy
We provide specialized pharmacovigilance expertise across Italy’s pharmaceutical heartlands:
Global Manufacturing Giants (Lombardy/Lazio): Managing high-volume aggregate reporting for innovative and generic portfolios produced in Italy for global export.
Biotech & Advanced Therapy Innovators: Drafting complex PBRERs for breakthroughs in oncology, rare diseases, and cell/gene therapies emerging from Italian research clusters.
National Specialty Pharma: Supporting Italy’s robust medium-sized pharmaceutical sector in maintaining compliance with Legislative Decree 219/06.
Local Pharmacovigilance Contact Persons (RPPV): Providing technical back-end support to the mandatory Italian-resident National Contact Person who must be registered in the RNF.
Clinical Trial Sponsors: Managing transition safety reports and DSURs under the newly fully implemented Regulation (EU) 536/2014 (CTR).
Our PSUR & PBRER Services
Our scientific precision matches the Italian reputation for pharmaceutical excellence and clinical rigor:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully integrated with the new EMA IRIS digital submission workflows.
National Pharmacovigilance Network (RNF) Integration: Utilizing data from Italy’s centralized RNF system to validate and assess safety signals specifically for the Italian population.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data to provide a compelling clinical narrative for the PRAC and AIFA.
Signal Detection & Management: Utilizing scientific methodologies to monitor and evaluate signals from EudraVigilance, global databases, and Italian-specific spontaneous reporting.
Technical Gap Analysis: Pre-audit reviews to ensure safety reports meet the expectations of AIFA GPvP inspections.
Why Pharma Leaders in Italy Choose PSUR Central
"Scientific rigor for Europe's leading pharmaceutical manufacturing powerhouse."
National Regulatory Experts: We understand the unique Italian requirement for a Local Pharmacovigilance Contact Person registered in the RNF and provide the technical writing to support their legal mandate.
2025 Regulatory Readiness: Fully operational on the IRIS platform, ensuring that all 2025 submission cycles are managed with technical precision and zero delays.
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, AIFA, and the US FDA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Legislative Decree 219/06 (Art. 129-135): The legal foundation for pharmacovigilance in Italy.
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
AIFA Technical Guidelines: Specific national requirements for reporting and the RNF.
Get Started: Partner With Us
To initiate a customized project for your Italian-based operations, we typically require:
Product Portfolio and target markets (Italy, EU, USA, Global).
Approved Labeling: The Italian SmPC (Riassunto delle Caratteristiche del Prodotto) and Patient Leaflet (Foglio Illustrativo).
Estimated Patient Exposure: Units sold or patient-years (Global and Italy-specific).
Summary of ICSRs: Line listings and tabulations from the RNF and your global safety database.
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.