China Pharmacovigilance Systems
Establish audit-ready GVP and GCP structures in mainland China. We align your global safety protocols with local regulatory expectations through bilingual expert oversight.
What We Offer
Services for pharmaceutical companies operating in or entering the Chinese market smoothly.
China GVP Inspection & Audit Support
GCP Mock Inspection/Audit
Regulatory Intelligence
Comprehensive preparation and support for pharmacovigilance inspections and audits in China. We provide documentation review, compliance assessment, inspection readiness preparation, and remote or on-site audits of your local partners.
Mock GCP inspections and audits tailored for overseas sponsors' investigational sites and contract research organizations (CROs) in China. We conduct realistic audit scenarios to identify gaps and ensure readiness for regulatory inspections.
Expert guidance on navigating China's GVP requirements, regulatory submissions, and compliance with NMPA standards. We provide comprehensive support for regulatory intelligence, gap analysis, and product registration.
The Method
Path to Audit Readiness
Gap Analysis
System Localization
Continuous Oversight
We evaluate your current global pharmacovigilance system against active NMPA guidelines to identify local compliance variances.
Our bilingual experts draft localized standard operating procedures and configure local safety reporting databases.
We deploy local safety representatives to manage daily signal detection, literature reviews, and regulatory submissions.
Secure Your China Compliance
Partner with local experts to de-risk your pharmacovigilance operations and maintain absolute compliance under active NMPA scrutiny.