PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for the UK Life Sciences Sector: MHRA | 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 the United Kingdom’s world-leading pharmaceutical and biotech industries.
In the post-Brexit regulatory environment, UK Marketing Authorization Holders (MAHs) face the unique challenge of navigating the MHRA’s independent submission portal while maintaining alignment with global and European safety standards. Since 2008, we have supported UK-based firms—from the high-growth biotechs in Cambridge and Oxford to the manufacturing hubs in the North West and Scotland—ensuring their safety documentation is authority-ready for both Great Britain and Northern Ireland.
Who We Support in the United Kingdom
We provide specialized pharmacovigilance expertise to the core of the UK’s Life Sciences ecosystem:
Global R&D Innovators (The Golden Triangle): Managing complex PBRERs for first-in-class therapies, including advanced cell and gene therapies and oncology.
Generic & Specialty Pharma (South East & Midlands): Drafting periodic reports for established portfolios, ensuring compliance with both the UK PBRER requirements and the EU PSUR repository for Northern Ireland.
Orphan Drug Developers: Managing safety reporting for niche medicines with "Orphan" designation under the MHRA’s specific regulatory pathways.
Import/Export Leaders: Supporting firms managing dual-compliance for products marketed in the UK and the European Economic Area (EEA).
Regulatory Affairs Consultancies: Providing niche medical writing and signal detection support for aggregate safety reporting cycles.
Our PSUR & PBRER Services
We offer scientific excellence that matches the UK’s reputation for rigorous clinical oversight and academic precision:
MHRA-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, tailored to the MHRA’s specific expectations for Great Britain (GB) submissions.
Windsor Framework Compliance: Managing the technical split for Northern Ireland (NI), ensuring PSURs for NI are submitted via the EMA PSUR Repository while GB reports are filed with the MHRA.
Signal Detection & Analysis: Utilizing scientific methodologies to validate and assess safety signals using data from the Yellow Card Scheme, CPRD, and global sources.
Benefit-Risk Synthesis: High-level medical evaluation that moves beyond administrative data to provide a robust clinical defense of your product’s profile.
Technical Gap Analysis: Pre-audit reviews of safety reports to ensure they meet the expectations of MHRA GPvP (Good Pharmacovigilance Practice) inspections.
Why Pharma Leaders in the UK Choose PSUR Central
"Scientific rigor for one of the world’s most advanced regulatory environments."
Post-Brexit Specialists: We understand the nuances of the UK’s independent regulatory status, including the management of UK Reference Dates and submission portals.
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 MHRA, EMA, and US FDA.
Confidentiality & Precision: Professional execution with a strict adherence to UK GDPR and global submission timelines.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
MHRA GvP Modules: The UK standard for post-marketing safety reporting.
ICH E2C (R2): The global gold standard for PBRER/PSUR.
EU GVP Module VII: For compliance regarding Northern Ireland and broader European markets.
US FDA 21 CFR 314.80: Post-marketing safety reporting for US-approved products.
Get Started: Partner With Us
To initiate a customized project for your UK-based operations, we typically require:
Product Portfolio and target markets (GB, NI, EU, USA, Global).
Approved Labeling: The UK SmPC (Summary of Product Characteristics) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (UK-specific and global).
Summary of ICSRs: Line listings and tabulations from the MHRA Yellow Card scheme and your safety database.
Submission Calendar: Coordination with UK-specific and 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.