PSUR Central – Global PSUR & PBRER Services
Precision Compliance for Slovakia’s Pharma Sector: EMA | ŠÚKL | ICH | NMPA | 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 Slovakia’s established manufacturers and emerging biotech innovators.
As Slovakia strengthens its role as a key European hub for generics, vaccines, and ophthalmology, the complexity of maintaining global and EU-wide marketing authorizations has increased. Since 2008, we have supported Slovakian firms in navigating the EU GVP Modules and the newly implemented IRIS platform requirements, ensuring that safety documentation meets the rigorous standards of both the EMA and the Slovak State Institute for Drug Control (ŠÚKL).
Who We Support in Slovakia
We provide specialized pharmacovigilance expertise to the diverse tiers of the Slovak life sciences industry:
National Leaders & Generic Manufacturers: Managing global safety portfolios for legacy brands in Hlohovec and Šarišské Michaľany for exports to the EU and beyond.
Specialized Biologics & Vaccine Units: Drafting complex PBRERs for immunological products and sterile dosage forms.
Ophthalmology & Niche Pharma: Supporting developers of specialized generics in meeting the high clinical data standards of the EMA and US FDA.
MNC Production Sites: Providing overflow aggregate reporting support for international giants with manufacturing facilities in Slovakia.
Regulatory & Quality Teams: Addressing ŠÚKL observations and preparing for national or EMA-led GVP inspections.
Our PSUR & PBRER Services
We offer scientific excellence that matches Slovakia's tradition of pharmaceutical manufacturing and R&D:
EMA-Compliant PBRER Preparation: Professional 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 newly mandated by the EMA as of 2025.
EURD List Alignment: Synchronizing submission cycles with the EU Reference Date (EURD) list to ensure regulatory punctuality.
Signal Detection & Analysis: Scientific evaluation of adverse event trends using EudraVigilance and local ŠÚKL safety data.
Benefit-Risk Evaluation: Specialized assessments that provide a clear clinical justification for the continued authorization of your product in the EU.
Why Pharma Leaders in Slovakia Choose PSUR Central
"Scientific rigor for the manufacturing heart of Central Europe."
EU Regulatory Experts: We specialize in the sophisticated technical writing required to pass the Pharmacovigilance Risk Assessment Committee (PRAC) reviews.
Science-Driven Quality: We move beyond data collation, providing deep-dive clinical evaluations that prove your product's benefit-risk profile.
Global Export Readiness: Extensive experience in harmonizing safety dossiers for firms exporting to high-stringency markets like the US, UK, and China.
100% Acceptance Rate: Our reports have been successfully accepted by the EMA and 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.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
EMA/PRAC Guidelines: Specific requirements for safety monitoring in the European Economic Area.
ŠÚKL Requirements: Local Slovak compliance for nationally authorized products and clinical trial safety.
Get Started: Partner With Us
To initiate a customized project for your Slovakian-based operations, we typically require:
Product Portfolio and target markets (Slovakia, 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 EU-specific).
Summary of ICSRs: Line listings and tabulations from EudraVigilance or your safety database.
Submission Calendar: Coordination with EURD list deadlines or ŠÚKL requirements.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.