PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Finland’s Life Science Innovators: EMA | Fimea | 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 Finland’s advanced pharmaceutical and biotechnology sectors.
In a nation renowned for its high standards in drug safety and biobanking—from the medical clusters in Helsinki and Turku to the innovation hubs in Oulu and Kuopio—maintaining rigorous regulatory documentation is vital. Since 2008, we have supported Finnish Marketing Authorization Holders (MAHs) in delivering scientifically robust aggregate reports that meet the stringent expectations of Fimea and the EMA.
Who We Support in Finland
We provide specialized pharmacovigilance expertise to Finland’s research-driven pharmaceutical landscape:
Innovative Biotech Firms: Drafting PBRERs and Risk Management Plans (RMPs) for cutting-edge therapies, including niche biologics and orphan drugs.
Specialty Generic Manufacturers: Managing periodic safety reporting for established portfolios in CNS, respiratory, and oncology.
Health-Tech & Med-Tech Leaders: Providing safety summaries for drug-device combinations and medical devices entering global markets.
MNC Subsidiaries: Localizing global safety data to comply with Finnish national requirements and Nordic regional standards.
Regulatory & Quality Teams: Addressing Fimea inquiries and ensuring readiness for EMA Pharmacovigilance (GVP) inspections.
Our PSUR & PBRER Services
We offer scientific excellence that matches Finland’s leadership in medical precision and digital healthcare:
EMA-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring 100% alignment with EU GVP Module VII.
Signal Detection & Analysis: Utilizing scientific methodologies to validate and assess potential safety signals using data from EudraVigilance and local Finnish registers.
Benefit-Risk Synthesis: Providing high-level medical evaluations that move beyond data collation to a comprehensive clinical narrative.
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 stands up to the scrutiny of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Why Finnish Pharma Leaders Choose PSUR Central
"Scientific rigor for the world’s most trusted pharmaceutical and research 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).
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 benchmark for PBRER/PSUR.
Fimea Guidelines: Finnish-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 Finnish-based operations, we typically require:
Product Portfolio and target markets (Finland, EU, 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.