PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Norway’s Life Science Hub: EMA | DMP | 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 Norway’s innovative pharmaceutical and biotechnology companies.
Norway is a global pioneer in utilizing high-quality health data for safety monitoring. In an ecosystem ranging from the Oslo Cancer Cluster to specialized manufacturing in Elverum and Porsgrunn, maintaining rigorous safety documentation is essential for global market access. Since 2008, we have supported Norwegian Marketing Authorization Holders (MAHs) in delivering scientifically robust aggregate reports that meet the high expectations of the EMA and the Norwegian Medical Products Agency (Direktoratet for medisinske produkter – DMP).
Who We Support in Norway
We provide specialized pharmacovigilance expertise to Norway’s research-driven life sciences landscape:
Oncology & Biotech Innovators (Oslo): Drafting complex PBRERs and Risk Management Plans (RMPs) for cutting-edge immunotherapies and radiopharmaceuticals.
Specialized Manufacturing Sites: Providing overflow aggregate reporting support for large-scale production facilities exporting to the EU and North America.
Marine Biotech & Natural Product Developers: Managing safety reporting for specialized bio-marine derived medicinal products.
MNC Subsidiaries: Localizing global safety data to comply with Norwegian national requirements and Nordic regional monitoring standards.
Regulatory & PV Managers: Addressing DMP inquiries and ensuring readiness for EMA-aligned Pharmacovigilance (GVP) inspections.
Our PSUR & PBRER Services
We offer scientific excellence that matches Norway’s commitment to patient safety and digital health excellence:
EMA-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring 100% alignment with EU GVP Module VII (applicable via the EEA agreement).
Signal Detection & Analysis: Utilizing scientific methodologies to validate and assess potential safety signals, leveraging data from EudraVigilance and Norwegian 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 submissions through the EMA IRIS portal.
Technical Gap Analysis: Auditing existing safety documentation to ensure it meets the highest standards of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Why Norwegian Pharma Leaders Choose PSUR Central
"Scientific rigor for the world’s most data-rich and trust-based pharmaceutical environment."
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 and other Level IV regulatory agencies (US FDA, PMDA).
EEA Compliance Specialists: We understand the nuances of the Norwegian market's integration with European regulatory systems.
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 EEA.
ICH E2C (R2): The global gold standard for PBRER/PSUR.
DMP Guidelines: Norwegian-specific requirements for pharmacovigilance and local 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 Norwegian-based operations, we typically require:
Product Portfolio and target markets (Norway, EU/EEA, USA, Global).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Patient Information Leaflet (PIL).
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 specific 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.