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
