JOINN’s team specializes in clinical R&D compliance, leveraging the Group’s extensive project portfolio to build a full-lifecycle GCP/GCLP quality management system. In strict alignment with ICH, NMPA and FDA global compliance standards, we deliver systematic, regular quality risk prevention services for innovative drugs, generics and medical device clinical programs.
•GCP quality system establishment
•GCP/GCLP compliance training
•Vendor quality management
•Project quality control oversight
•GCP/GCLP audit execution
Establishment Principles
•Compliant with national pharmaceutical laws
•Consistent with ICH-GCP & China GCP
•Complete, standardized and executable SOP documentation
System Architecture
•Systematic, standardized full-process governance
•Individualized quality evaluation for staff & trial sites
•End-to-end coverage of all business lines: macro policies, micro operation records
•Hierarchical deliverables: management policies, execution SOPs, operation manuals, recording templates to guarantee compliance quality
Full-chain GCP compliance training covering three tiers:
•General compliance: New hire onboarding, ICH/NMPA regulatory training, SOP standard operation training
•Specialized business training: Regulatory filing, PV full workflow, clinical medical service dedicated training
•Operation management training: Full-cycle PM project management, CRA monitoring skill training, department & project customized training
All training is embedded within the QA system to mitigate human compliance risks upfront, paired with graded defect closed-loop mechanisms for full quality control.
Metabolic diseases are highly prevalent worldwide. Preclinical research imposes stringent requirements on model specificity, stability and translational value.
•Rich project QC & audit experience
•Real-time global regulatory iteration alignment
•Cross-team coordinated remediation & quality-timeline balance
