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PSUR Central – Global PSUR & PBRER Services
Precision Compliance for the Czech Pharma Sector: SÚKL | 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 Czech Republic’s diverse life sciences industry—from established manufacturers of generics and biosimilars to innovative R&D biotech firms.
As the Czech Republic continues to modernize its pharmacovigilance (PV) framework, including the implementation of the PHV-6 version 4 guideline (effective January 2025), the demand for authority-ready safety documentation is at an all-time high. Since 2008, we have supported Marketing Authorization Holders (MAHs) in navigating the SÚKL and EMA requirements, ensuring scientific rigor and seamless submissions.
Who We Support in the Czech Republic
We provide specialized pharmacovigilance expertise across the Czech pharmaceutical landscape:
National Generic Champions: Managing global aggregate reporting for large-scale portfolios in Prague and Södertälje (Sandoz/Zentiva heritage) for exports to the EU and beyond.
Innovative Biotech & Vaccine Manufacturers: Drafting complex PBRERs for immunologicals and sterile dosage forms in facilities in Brno and Olomouc.
Specialized API & Niche Pharma: Supporting manufacturers of specialized actives and niche generics in meeting high-stringency clinical standards.
Local Contact Persons for PV (LPPV): Providing technical bandwidth to Czech-based contact persons who must be fluent in Czech or Slovak and reachable via a Czech country code.
Regulatory Teams Facing SÚKL Inspections: Addressing SÚKL (Státní ústav pro kontrolu léčiv) observations and preparing defensible safety dossiers.
Our PSUR & PBRER Services
We offer scientific excellence that matches the Czech Republic’s reputation for pharmaceutical precision:
SÚKL-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring complete alignment with EU GVP Module VII.
IRIS Platform & PSUR Repository Management: Handling the technical submission requirements mandated by the EMA and SÚKL for 2025, including IRIS-affiliated contact management.
Local Signal Detection & Analysis: Scientific evaluation of adverse event trends using EudraVigilance and local safety data, including mandatory narrative fields in the reporter's native language for Czech-specific ICSRs.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data collation to provide a comprehensive clinical justification for your product.
PHV-6 version 4 Alignment: Ensuring your PSMF and aggregate reports reflect the 2025 updates regarding QPPV and local contact person reporting.
Why Pharma Leaders in the Czech Republic Choose PSUR Central
"Scientific rigor for Central Europe’s pharmaceutical manufacturing heart."
2025 Guideline Specialists: Fully prepared for the PHV-6 v.4 transition and the mandatory use of the IRIS platform for PSUR management as of late 2025.
Science-Driven Quality: We move beyond administrative data to provide deep-dive clinical evaluations that satisfy both SÚKL and the PRAC.
Local Insight, Global Reach: We understand the Czech requirement for a local contact person fluent in Czech/Slovak while managing global safety portfolios.
100% Acceptance Rate: Our reports have a perfect track record with SÚKL and other National Competent Authorities across the EEA.
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.
SÚKL PHV-6 Guideline (v.4): The local Czech benchmark for PV systems and contact persons.
Act No. 378/2007 Coll. (Act on Pharmaceuticals): The legal foundation for medicine regulation in the Czech Republic.
ICH E2C (R2): The global gold standard for PBRER/PSUR.
Get Started: Partner With Us
To initiate a customized project for your Czech-based operations, we typically require:
Product Portfolio and target markets (Czech Republic, EU, Global).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and Czech-specific).
Summary of ICSRs: Line listings and tabulations from SÚKL and your global safety database.
Submission Calendar: Coordination with EURD list deadlines or 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.