PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Greece’s Pharmaceutical Sector: EOF | 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 Greece’s dynamic pharmaceutical landscape.
Greece is home to one of Europe’s most robust pharmaceutical manufacturing bases, with the sector contributing over 3% of the national GDP. From the industrial zones in Attica to the growing R&D clusters in Thessaloniki, Greek manufacturers are global leaders in high-quality generics and biosimilars. As of 2025, with the enforcement of Law 5173/2025 and the mandatory shift to the EMA IRIS platform, maintaining rigorous safety documentation is vital for both local market access and international export success.
Who We Support in Greece
We provide specialized pharmacovigilance expertise to the key players in the Hellenic life sciences industry:
National Generic Champions: Supporting Greece’s top exporters in managing global aggregate reporting cycles for diverse portfolios in Cardiology, Oncology, and CNS.
Innovative Biotech & Startup Spin-offs: Drafting complex PBRERs for breakthrough therapies emerging from Greek research institutes and university collaborations.
Local Pharmacovigilance Contact Persons (LCPPV): Providing technical back-end support to the mandatory Greek-resident LCPPV to ensure seamless communication with EOF in the Greek language.
MAHs & Local Representatives: Assisting companies in fulfilling the new 2025 EOF Unique Code requirements and ensuring safety profiles align with updated Greek labeling laws.
Scientific Offices: Managing the transition to the IRIS platform for all post-authorization safety procedures, ensuring zero disruption in submission timelines.
Our PSUR & PBRER Services
Our scientific precision matches the high clinical standards of the Greek medical community:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully integrated with the new EMA IRIS digital submission workflows mandatory as of January 2025.
Local Signal Detection (Yellow Card System): Utilizing scientific methodologies to validate and assess safety signals specifically for the Greek population, incorporating data from the EOF Yellow Card (Κίτρινη Κάρτα) system.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data to provide a compelling clinical narrative for the PRAC and EOF.
Greek Language Compliance: Ensuring that all Risk Minimization Measures (RMMs), educational materials, and summary safety information are accurately translated and culturally adapted for the Greek market.
Technical Gap Analysis: Pre-audit reviews to ensure reports meet the specific requirements of Ministerial Decision D3(a)6030/2025 and EU GVP standards.
Why Pharma Leaders in Greece Choose PSUR Central
"Scientific rigor for one of Europe's most dynamic and export-oriented pharmaceutical markets."
2025 Regulatory Specialists: We are fully operational on the IRIS platform and versed in the Law 5173/2025 updates, ensuring your 2025 submissions avoid technical rejections or fines.
LCPPV Support Excellence: We provide the technical bandwidth your local Greek safety officer needs to manage complex global dossiers while remaining compliant with national mandates.
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 EOF, the EMA, and the US FDA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Law 5173/2025: The latest Tongan/Greek national framework for pharmaceutical safety and labeling.
Ministerial Decision D3(a)6030/2025: Specifically regarding enhanced market monitoring and safety features.
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
Get Started: Partner With Us
To initiate a customized project for your Greek-based operations, we typically require:
Product Portfolio and target markets (Greece, EU, USA, Global).
Approved Labeling: The Greek SmPC (ΠΧΠ) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and Greece-specific).
Summary of ICSRs: Line listings and tabulations from the EOF database and your global 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.