GXP Third-Party Audits
GXP：
Good Clinical Practice, GCP
Good Clinical Laboratory Practice, GCLP
Good Laboratory Practice, GLP
Good Manufacturing Practice, GMP
Good Distribution Practice, GDP
Good Supply Practice, GSP
Audit Service：
Preclinical Contract Research Organization (CRO) Audit
Investigator site audit, including routine audit and for-cause audit
Clinical vendor evaluation and inspection, including but not limited to Phase I Unit, CROs, central laboratories, bioanalytical laboratories, NGS labs, and drug warehouses
Review of clinical trial documents such as trial protocols and ICFs
Audit of clinical TMFs
Audit of clinical trial data, including audits of databases and TFLs
Audit of clinical study reports
Computerized System Validation Audit
Assistance with Authority Inspections/Investigations
Mock NMPA/OECD/FDA GLP inspection
Mock CFDI/EMA/FDA GCP inspection
Assist sponsors, CROs, and investigators in preparing for authority inspections
Support and coordination for authority inspections
Response and review of authority inspection/investigation reports
Quality System Consulting
Process evaluation and analysis
Gap analysis
Development of Standard Operating Procedures, policies, and guidance
Management and maintenance of Standard Operating Procedure documents
Customized Training
Training on GLP/GCP-related topics
Training for QAs
Training for investigators and CRC
Training on vendor management
Training for regulatory agency inspection preparation
Training on Computerized System Validation
Computerized System Validation
Validation assessment and gap analysis
Validation document drafting
Validation testing
Computerized System Validation training
Location：Consultation Service > GXP Third-Party Audits