PSUR Central – Global PSUR & PBRER Services
Navigating China’s Regulatory Evolution: NMPA | US FDA | EU | ICH Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the pharmaceutical leaders and biotech innovators operating within Mainland China and the Greater Bay Area.
With China’s full membership in ICH and the rigorous modernization of NMPA safety reporting mandates, "authority-ready" documentation is the key to maintaining market authorization. Since 2008, we have partnered with global firms and domestic leaders in hubs like Shanghai (Zhangjiang High-Tech Park), Beijing, and Suzhou to deliver scientifically robust safety reports that bridge the gap between Chinese domestic data and international submission standards.
Who We Support in China
We provide specialized pharmacovigilance expertise to the core of China's "Pharma Valley":
Domestic "Big Pharma" Exporters: Managing global safety reporting for Chinese firms expanding into the US (ANDA/NDA), EU, and South East Asia.
MNC Subsidiaries in China: Localizing global safety data to meet NMPA periodic reporting requirements (PSUR/DSUR) for imported drugs.
Biotech & Cell/Gene Therapy Innovators: Handling complex safety data for high-value biologicals and breakthrough therapies during post-marketing surveillance.
Contract Research Organizations (CROs): Partnering to provide niche medical writing and signal detection expertise for aggregate reporting.
Regulatory Affairs Teams: Addressing NMPA technical queries or preparing for GVP (Good Pharmacovigilance Practice) inspections.
Our PSUR & PBRER Services
We offer scientific excellence that matches China’s rapid pharmaceutical innovation:
NMPA-Compliant PSUR/PBRER Drafting: Expert preparation of reports in accordance with China's "Administrative Measures on Reporting and Monitoring of Adverse Drug Reactions."
Global PBRER Preparation (ICH E2C R2): High-level technical writing for global portfolios, ensuring consistency between Chinese domestic data and global safety narratives.
Signal Detection & Management: Utilizing scientific methodologies to identify, validate, and evaluate potential safety signals within the massive Chinese patient population.
Technical Gap Analysis: Auditing existing safety data and legacy reports to ensure they meet modern NMPA GVP and international standards.
Medical Review & Scientific Writing: Every report is scrutinized by medical experts to ensure the benefit-risk profile is scientifically defensible.
Why Pharma Leaders in China Choose PSUR Central
"Scientific rigor for the world's most dynamic pharmaceutical market."
ICH Alignment: As China harmonizes with global standards, our 15+ years of experience with ICH-format reports ensures your submissions are world-class.
Bridging Local & Global Data: We specialize in integrating Chinese domestic safety data into global aggregate reports for international health authorities.
Audit-Ready Documentation: Our reports are built to withstand the scrutiny of both the NMPA and international Level IV regulators like the US FDA and EMA.
Confidentiality & Speed: Professional execution with strict adherence to submission windows and rigorous data security protocols.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
NMPA GVP (China Good Pharmacovigilance Practice): The local standard for safety monitoring.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
US FDA 21 CFR 314.80: Post-marketing safety reporting for the US market.
EU GVP Module VII: European Union periodic safety reporting standards.
Get Started: Strategic Partnership
To provide a customized technical scope for your China-based operations, we typically require:
Product Portfolio and target markets (Mainland China vs. Global).
Approved Labeling: ChP (Chinese Pharmacopoeia) labeling or global reference labeling (CCDS/SmPC).
Estimated Patient Exposure: Units sold or patient-years specifically in the Chinese market and globally.
Summary of ICSRs: Line listings and tabulations from your local or global safety database.
Submission Calendar: NMPA and international deadlines.
Contact PSUR Central today to ensure your safety compliance in China and beyond is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.