PSUR Central – Global PSUR & PBRER Services
To adapt the PSUR Central webpage for the Hungarian market, the messaging highlights Hungary’s role as a leading pharmaceutical hub in Central and Eastern Europe (CEE), its strong tradition in drug research, and its membership in the European Union. It focuses on compliance with the European Medicines Agency (EMA) and the National Institute of Pharmacy and Nutrition (OGYÉI).
PSUR Central – Global PSUR & PBRER Services
Expert Compliance for Hungary’s Pharma Leaders: EMA | OGYÉI | 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 Hungary’s innovative manufacturers and Marketing Authorization Holders (MAHs).
With Hungary serving as a strategic gateway to the EU and a center for complex generic and biotechnological production (notably in Budapest and Debrecen), maintaining rigorous Pharmacovigilance (PV) standards is critical. Since 2008, we have supported Hungarian firms in navigating the transition from local requirements to the strict mandates of the EU GVP Modules, ensuring seamless market retention across the European Economic Area.
Who We Support in Hungary
We provide specialized pharmacovigilance expertise to one of the most established pharma sectors in Europe:
Hungarian Domestic Leaders: Supporting heritage brands in managing global safety portfolios for exports to the EU, CIS, and North America.
MNC Manufacturing Hubs: Providing aggregate reporting support for international giants with large-scale production facilities in Hungary.
Biotech & Biosimilar Developers: Handling complex safety data and Risk Management Plans (RMP) for high-value biological products.
Generic Exporters: Managing PBRERs for products registered via Decentralized (DCP) and Mutual Recognition (MRP) procedures.
Regulatory & Quality Heads: Addressing OGYÉI (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet) observations and preparing for EMA inspections.
Our PSUR & PBRER Services
We offer scientific excellence that matches Hungary’s reputation for pharmaceutical innovation and clinical precision:
EMA-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, aligned with the EU Good Pharmacovigilance Practices (GVP) Module VII.
EURD List Monitoring: Ensuring your PSUR submissions are perfectly timed with the EU Reference Date (EURD) list and data lock points.
Signal Detection & Management: Utilizing scientific methodologies to identify, validate, and evaluate potential safety signals from the EudraVigilance database and local sources.
Benefit-Risk Evaluation: Specialized assessments for complex formulations, focusing on maintaining a positive profile for European health authorities.
Technical Gap Analysis: Auditing existing PSURs to ensure they withstand the scrutiny of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Why Pharma Leaders in Hungary Choose PSUR Central
"Scientific rigor for the historic pharmaceutical heart of Central Europe."
EU-Centric Expertise: We specialize in the sophisticated technical writing required to clear the EMA’s stringent regulatory hurdles and PRAC assessments.
Science-Driven Quality: We move beyond data collation, providing deep-dive clinical evaluations that demonstrate your product's ongoing safety and efficacy.
Multilingual Data Integration: Expertise in synthesizing global safety data into the English-language dossiers required for European submissions.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across all major EU National Competent Authorities.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
EU GVP Module VII: The European Union standard for Periodic Safety Update Reports.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
EMA/PRAC Guidelines: Specific requirements for safety monitoring in the EEA.
OGYÉI Requirements: Local compliance for products marketed within Hungary.
Get Started: Partner With Us
To initiate a customized project for your Hungarian-based operations, we typically require:
Product Portfolio and target markets (EU, CIS, Global).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Patient Information Leaflet (PIL).
Estimated Patient Exposure: Units sold or patient-years specifically in the EEA and globally.
Summary of ICSRs: Line listings and tabulations from EudraVigilance or your local safety database.
Submission Schedule: Alignment with the EURD list or specific national requirements.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.