PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for Slovenia’s Biopharma Hub: JAZMP | 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 Slovenia’s export-oriented pharmaceutical leaders and innovative biotech firms.
Slovenia is a pharmaceutical powerhouse in Central Europe, with the sector contributing over 6% of the national GDP. From the global headquarters of Krka in Novo Mesto to the high-tech innovative manufacturing sites of Novartis Slovenia in Ljubljana and Mengeš, the "Slovenia Biotech Hills" initiative is positioning the country as a leader in biologics and advanced therapies. Since 2008, we have supported Slovenian Marketing Authorization Holders (MAHs) in ensuring their safety dossiers meet the rigorous expectations of JAZMP and the EMA.
Who We Support in Slovenia
We provide specialized pharmacovigilance expertise across the Slovenian life sciences landscape:
Global Generic Leaders (Novo Mesto/Ljubljana): Managing high-volume, multi-regional PBRER cycles for diverse portfolios exported to over 70 countries.
Innovative Medicine & Biologic Manufacturers: Drafting complex safety reports for biologicals, biosimilars, and advanced therapies (ATMPs) produced in Slovenia’s world-class facilities.
Regional Regulatory Hubs: Supporting companies that use Slovenia as a "Reference Member State" (RMS) for decentralized (DCP) and mutual recognition (MRP) procedures.
Domestic MAHs & Wholesalers: Ensuring that products registered nationally in Slovenia comply with the Medicinal Products Act and JAZMP’s 2025 electronic reporting mandates.
Local Contact Persons for PV: Providing technical support to Slovenian-resident safety officers for signal detection, medical writing, and JAZMP portal submissions.
Our PSUR & PBRER Services
Our scientific precision matches Slovenia’s reputation for pharmaceutical quality and innovation:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully integrated with the mandatory EMA IRIS digital submission workflows effective January 2025.
JAZMP-Specific Reporting Support: Managing the technical requirements for safety data submission to the Slovenian National Pharmacovigilance Centre.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data collation to provide a robust clinical justification for the PRAC and JAZMP.
Signal Detection & Analysis: Utilizing scientific methodologies to validate safety signals from EudraVigilance and local Slovenian reporting systems.
Bilingual Documentation: Ensuring all summary safety information and risk minimization materials comply with Slovenian and English language requirements.
Why Pharma Leaders in Slovenia Choose PSUR Central
"Scientific rigor for Europe's most innovative and export-driven pharmaceutical hub."
2025 Regulatory Specialists: Fully prepared for the IRIS platform transition and JAZMP's strategic focus on AI and digital transformation in 2025.
Export-Oriented Excellence: We understand the challenges of managing safety dossiers for products marketed across the EU, CIS, and MENA regions from a Slovenian base.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
100% Acceptance Rate: Our reports have a perfect track record with JAZMP, the EMA, and other Level IV regulatory agencies (US FDA, PMDA).
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Medicinal Products Act (Official Gazette RS, No. 17/14 and 66/19): The legal foundation for medicine regulation in Slovenia.
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
JAZMP PHV Guidelines: Specific national requirements for pharmacovigilance and reporting.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
Get Started: Partner With Us
To initiate a customized project for your Slovenian-based operations, we typically require:
Product Portfolio and target markets (Slovenia, EU, Global).
Approved Labeling: The SmPC (Povzetek glavnih značilnosti zdravila) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and Slovenia-specific).
Summary of ICSRs: Line listings and tabulations from the JAZMP database or your global safety database.
Submission Calendar: Coordination with EURD list deadlines or specific national 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.