PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Sweden’s Life Science Innovators: EMA | Läkemedelsverket | 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 Sweden’s sophisticated pharmaceutical, biotech, and MedTech sectors.
Sweden is at the forefront of global healthcare—from the pioneering work at the Karolinska Institute to the massive manufacturing and R&D clusters in Södertälje and Gothenburg. In such a high-stakes environment, your safety documentation must reflect the same level of scientific excellence as your products. Since 2008, we have supported Swedish Marketing Authorization Holders (MAHs) in delivering aggregate reports that meet the rigorous clinical expectations of the EMA and Läkemedelsverket.
Who We Support in Sweden
We provide specialized pharmacovigilance expertise to the core of the Nordic life science ecosystem:
Global R&D Leaders: Supporting Sweden’s largest pharmaceutical exporters in managing complex, multi-national aggregate reporting cycles for innovative therapies.
Biotech & Orphan Drug Pioneers: Drafting PBRERs and Risk Management Plans (RMPs) for breakthrough biologicals and niche treatments.
Specialty Generic Manufacturers: Managing safety reporting for established portfolios in Respiratory, Oncology, and Cardiovascular health.
AstraZeneca-Related Supply Chain & SMEs: Providing overflow technical support for the dense network of suppliers and specialized firms in the Stockholm-Uppsala region.
Regulatory & PV Managers: Addressing Läkemedelsverket technical queries and ensuring audit readiness for GVP inspections.
Our PSUR & PBRER Services
We offer scientific excellence that aligns with Sweden’s reputation for clinical precision and patient safety:
EMA-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring 100% alignment with EU GVP Module VII.
Signal Detection & Registry Integration: Utilizing scientific methodologies to validate safety signals, leveraging data from EudraVigilance and Sweden’s unique national health registries.
Benefit-Risk Synthesis: High-level medical evaluation that moves beyond data to provide a compelling clinical narrative for global regulators.
EURD List & IRIS Management: Synchronizing submission cycles with the EU Reference Date (EURD) list and managing digital submissions via the EMA 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 Swedish Pharma Leaders Choose PSUR Central
"Scientific rigor for one of the world’s most advanced pharmaceutical nations."
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 profile is scientifically defensible and clinically robust.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across the EMA, Läkemedelsverket, and US FDA.
Confidentiality & Precision: Professional execution with a strict adherence to European data privacy standards (GDPR) and submission timelines.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
ICH E2C (R2): The global gold standard for PBRER/PSUR.
Läkemedelsverket Guidelines: Swedish-specific requirements for pharmacovigilance and reporting.
EMA/PRAC Requirements: European expectations for signal management and benefit-risk evaluation.
Get Started: Partner With Us
To initiate a customized project for your Swedish-based operations, we typically require:
Product Portfolio and target markets (Sweden, 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 your safety database or EudraVigilance.
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.