JOINN’s PV team has extensive experience across marketed and investigational assets, building a standardized, audit-ready end-to-end pharmacovigilance compliance system. We deliver full-cycle clinical + post-marketing PV one-stop services for chemical, biological and traditional Chinese innovative/generic drugs, plus biomedical technology transformation projects, fully aligned with latest ICH and NMPA PV regulations.
Differentiated from template-based PV providers, our proprietary safety event database and abundant real-case experience enable rapid risk identification, precise adverse event adjudication and efficient signal evaluation & regulatory reporting. We resolve core industry pain points: incomplete PV systems, delayed reporting, unprofessional signal handling and high audit risks, enabling full-lifecycle drug safety compliance control.
• PV system establishment & optimization
• Case report management, query resolution, SAE consistency audit, literature surveillance
• Periodic safety reports (DSUR / PSUR)
• Signal detection & evaluation management
• Risk management project oversight
• PV system & document administration
• Regulatory inspection support & response
• Multi-indication cross-drug project experience
• Audit-proven mature compliance systems
• End-to-end closed-loop safety control
• Cross-functional rapid response team
