PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for Ireland’s Life Science Hub: EMA | HPRA | 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 elite pharmaceutical and biotech sectors operating across Ireland.
Ireland is home to 24 of the world’s top 25 pharmaceutical companies, with major clusters in Dublin, Cork (Ringaskiddy), and Galway. As a critical gateway for products entering the European Union and the United States, maintaining a high-tier Pharmacovigilance (PV) infrastructure is a business imperative. Since 2008, we have served as a technical partner to Irish-based firms, ensuring their safety documentation satisfies the rigorous scientific standards of the HPRA and the EMA.
Who We Support in Ireland
We provide specialized pharmacovigilance expertise to Ireland's world-class life sciences ecosystem:
MNC Global HQs & Regional Hubs (Dublin/Cork): Managing massive, multi-region aggregate reporting cycles for innovative and legacy portfolios.
Biopharmaceutical Leaders: Drafting complex PBRERs for biosimilars, monoclonal antibodies (mAbs), and advanced therapy medicinal products (ATMPs).
Indigenous Specialty Pharma: Supporting high-growth Irish firms in scaling their regulatory documentation for global market entries.
Medical Device & Combo-Product Innovators: Providing safety summaries for drug-device combinations in accordance with MDR/IVDR and GVP standards.
Qualified Persons for PV (QPPVs): Assisting Ireland-based QPPVs with overflow aggregate reporting, signal detection, and medical writing.
Our PSUR & PBRER Services
We offer scientific excellence that matches Ireland’s reputation for pharmaceutical manufacturing and clinical quality:
EMA-Compliant PBRER Preparation: High-level drafting in the ICH E2C (R2) format, ensuring complete alignment with EU GVP Module VII.
Signal Detection & Management: Utilizing scientific methodologies to validate and assess potential safety signals using data from EudraVigilance and global databases.
Benefit-Risk Synthesis: Expert medical evaluation that moves beyond administrative data to provide a robust clinical defense of your product’s profile.
IRIS & EURD List Management: Coordinating submission timelines with the EU Reference Date (EURD) list and managing submissions via the EMA’s IRIS portal.
Technical Gap Analysis: Pre-audit reviews of safety reports to ensure they meet the expectations of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).
Why Pharma Leaders in Ireland Choose PSUR Central
"Scientific rigor for the global heart of pharmaceutical manufacturing."
High-Stringency Expertise: We specialize in the sophisticated technical writing required to clear the world’s most demanding health authority reviews.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety narrative is scientifically defensible and clinically robust.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across the EMA, HPRA, and US FDA.
Scalability for Global Portfolios: We provide the technical bandwidth to handle large-scale global reporting for companies with thousands of marketing authorizations.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
EU GVP Module VII: The mandatory European standard for Periodic Safety Update Reports.
ICH E2C (R2): The global gold standard for PBRER/PSUR.
HPRA Pharmacovigilance Guidelines: Local Irish requirements and national safety monitoring standards.
US FDA 21 CFR 314.80: Post-marketing safety reporting for US-approved products managed from Irish HQs.
Get Started: Partner With Us
To initiate a customized project for your Irish-based operations, we typically require:
Product Portfolio and target markets (Ireland, EU, USA, 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 EudraVigilance or your safety database.
Submission Calendar: Coordination with EURD list deadlines or global 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.