PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Denmark’s Life Science Leaders: EMA | Lægemiddelstyrelsen | 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 sophisticated pharmaceutical, biotech, and medical device clusters of Denmark.
In a nation that sets the global benchmark for healthcare innovation—from insulin and neuroscience to immunology—maintaining impeccable safety standards is non-negotiable. Since 2008, we have supported Danish Marketing Authorization Holders (MAHs) in hubs like Copenhagen, Aarhus, and Kalundborg to deliver scientifically rigorous aggregate reports that satisfy the high expectations of the EMA and the Danish Medicines Agency.
Who We Support in Denmark
We provide specialized pharmacovigilance expertise to the core of the Medicon Valley:
Global Innovation Leaders: Supporting Denmark’s heritage pharmaceutical giants in managing complex global safety portfolios for innovative products and biosimilars.
Biotech & High-Growth Startups: Drafting PBRERs and Risk Management Plans (RMPs) for first-in-class therapies navigating post-marketing surveillance.
Specialized Generic & Specialty Pharma: Managing safety reporting for niche therapeutic areas, including CNS, metabolic disorders, and dermatology.
CMO & Manufacturing Hubs: Providing overflow aggregate reporting support for global production facilities based in Denmark.
Regulatory Affairs Departments: Addressing Lægemiddelstyrelsen inquiries and preparing for EMA/GVP audits.
Our PSUR & PBRER Services
We offer scientific excellence that matches Denmark’s reputation for clinical precision and digital health leadership:
EMA-Compliant PBRER Preparation: Professional drafting in the ICH E2C (R2) format, ensuring complete alignment with EU GVP Module VII.
Signal Detection & Analysis: Utilizing advanced scientific methodologies to evaluate potential safety signals from EudraVigilance and Danish 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: Coordinating submission cycles with the EU Reference Date (EURD) list and managing submissions via the EMA IRIS platform.
Technical Gap Analysis: Auditing existing safety documentation to ensure it meets the highest standards of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Why Denmark’s Life Science Leaders Choose PSUR Central
"Scientific rigor for the world’s most advanced pharmaceutical ecosystem."
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 sound.
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 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.
Lægemiddelstyrelsen Guidelines: Danish-specific requirements for post-marketing safety and reporting.
EMA/PRAC Requirements: Specific European expectations for signal management and benefit-risk evaluation.
Get Started: Partner With Us
To initiate a customized project for your Danish-based operations, we typically require:
Product Portfolio and target markets (Denmark, 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.