PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Israel’s Bio-Pharma Leaders: MoH | 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 Israel’s high-tech pharmaceutical giants and disruptive biotech startups.
With Israel serving as a global nerve center for R&D and complex manufacturing—anchored in hubs like Petah Tikva, Rehovot, and Jerusalem—maintaining authority-ready safety documentation is critical for both domestic stability and international export. Since 2008, we have partnered with Israeli Marketing Authorization Holders (MAHs) to deliver scientifically robust reports that comply with the Israel Ministry of Health (MoH) SOP No. 6 and international ICH E2C (R2) guidelines.
Who We Support in Israel
We provide specialized pharmacovigilance expertise to the "Start-Up Nation’s" pharmaceutical core:
Global Generic & Innovative Leaders: Supporting Israel’s multinational pharmaceutical powerhouses in managing massive aggregate reporting cycles for the US, EU, and Asia.
Biotech & Life Science Innovators: Drafting PBRERs and Risk Management Plans (RMP) for cutting-edge therapies emerging from the Weizmann Science Park and beyond.
Local Registration Holders (MAH): Assisting Israeli companies that act as the local representative for foreign manufacturers, ensuring all MoH safety mandates are met.
Specialized API & Formulation Units: Managing safety data for high-value active ingredients and complex delivery systems exported from facilities in Neot Hovav and Jerusalem.
Qualified Persons for PV (QPPV): Providing technical bandwidth to Israeli QPPVs for signal detection, medical writing, and responding to MoH Pharmaceutics Division queries.
Our PSUR & PBRER Services
Our scientific precision matches Israel’s reputation for clinical excellence and technological advancement:
MoH-Compliant PSUR/PBRER Preparation: Expert drafting in accordance with the Israel Ministry of Health SOP No. 6, which aligns with EU GVP Module VII standards.
ICH E2C (R2) Global Reporting: High-level technical writing for global portfolios, ensuring a single, "standalone" document that meets FDA and EMA expectations.
Signal Detection & Management: Utilizing scientific methodologies to identify and evaluate safety signals using data from the Israeli market and global safety databases.
2025 Regulatory Framework Support: Navigating the MoH's new "Regulatory Pilot" for expedited registration, ensuring safety documentation supports rapid market access.
Technical Gap Analysis: Pre-audit reviews of safety reports to ensure they are defensible during MoH inspections or global health authority audits.
Why Pharma Leaders in Israel Choose PSUR Central
"Scientific rigor for the world’s most innovative pharmaceutical ecosystem."
Western-Aligned Expertise: We specialize in the sophisticated technical writing required to clear EMA, FDA, and MoH reviews simultaneously.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible, moving beyond simple data tabulation.
Audit-Proven Success: Our reports have a 100% acceptance track record across all major Level IV regulatory agencies.
Reliability & Data Security: Professional execution with strict adherence to global submission timelines and rigorous data protection protocols.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Israel MoH SOP No. 6: "Reporting of Side Effects and New Safety Information."
ICH E2C (R2): The global benchmark for PBRER/PSUR.
EU GVP Module VII: European standard for periodic reporting.
US FDA 21 CFR 314.80: Post-marketing safety reporting mandates.
Get Started: Partner With Us
To initiate a customized project for your Israeli-based operations, we typically require:
Product Portfolio and target markets (Israel, USA, EU, Global).
Approved Labeling: The Israeli Physician's Leaflet and Reference Safety Information (CCDS/SmPC).
Estimated Patient Exposure: Units sold or patient-years (Global and Israel-specific).
Summary of ICSRs: Line listings and tabulations from the MoH and your global safety database.
Submission Calendar: Coordination with MoH requirements or global 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.