PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for Poland’s Pharma Industry: EMA | URPL | 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 Poland’s rapidly expanding pharmaceutical and biotech sectors.
With Poland serving as a major European manufacturing hub (centered in Warsaw, Łódź, and Poznań) and a leader in affordable medicine access, the demand for high-quality Pharmacovigilance (PV) documentation is paramount. Since 2008, we have partnered with Polish manufacturers and Marketing Authorization Holders (MAHs) to deliver scientifically rigorous safety reports that meet the strict mandates of the EU GVP Modules, facilitating seamless market authorization across the European Union.
Who We Support in Poland
We provide specialized pharmacovigilance expertise to one of Europe’s most dynamic pharmaceutical landscapes:
Polish National Champions: Supporting established domestic leaders in managing global safety portfolios for exports to the EU, CIS, and North America.
Generic Export Powerhouses: Drafting PBRERs for products registered via Decentralized (DCP) and Mutual Recognition (MRP) procedures across Europe.
Biotech & Biosimilar Innovators: Managing complex safety data and Risk Management Plans (RMP) for Poland's emerging biological and high-tech therapy sectors.
MNC Manufacturing Sites: Providing aggregate reporting support for international companies with large-scale production facilities in Poland.
Regulatory & PV Managers: Addressing URPL (Urząd Rejestracji Produktów Leczniczych) observations and preparing for EMA inspections.
Our PSUR & PBRER Services
We offer scientific excellence that matches Poland’s reputation for manufacturing quality and clinical expertise:
EMA-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring complete alignment with EU Good Pharmacovigilance Practices (GVP) Module VII.
EURD List Alignment: Managing your PSUR submission cycles in strict accordance with the EU Reference Date (EURD) list.
Signal Detection & Analysis: Utilizing scientific methodologies to identify and validate safety signals using data from EudraVigilance and local Polish sources.
Benefit-Risk Evaluation: Specialized assessments that demonstrate the ongoing positive profile of your medicinal products to European regulators.
Technical Gap Analysis: Auditing existing documentation to ensure it meets the current expectations of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Why Pharma Leaders in Poland Choose PSUR Central
"Scientific precision for the largest pharmaceutical market in Central and Eastern Europe."
EU Regulatory Specialists: We focus on the high-level technical writing required to pass PRAC assessments and National Competent Authority reviews.
Science-Driven Quality: We go beyond mere data tabulation to provide deep-dive clinical evaluations that justify your product's market presence.
Market-Specific Knowledge: Expertise in managing safety data for the diverse therapeutic areas dominant in the Polish market, including Cardiology, Oncology, and Anti-infectives.
Reliability & Audit Readiness: Our reports have a 100% acceptance track record across all major EU regulatory bodies.
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 international gold standard for PBRER/PSUR.
EMA/PRAC Guidelines: Specific European requirements for post-marketing safety monitoring.
URPL Requirements: Local Polish compliance for medicinal products and medical devices.
Get Started: Partner With Us
To initiate a customized project for your Polish-based operations, we typically require:
Product Portfolio and target markets (Poland, EU, 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 Schedule: Coordination with EURD list deadlines.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.