GLP Compliance

 

1. US and China GLP regulations
    

2. Review existing SOP’s
    

3. Generate SOP’s for all preclinical studies including toxicology and DMPK/bioanalysis, QA system, and veterinary cares
    

4. Generate SOP’s for validation system and practices with instrumentations, facility and IT systems including the electronic data acquisition software
    

5. Preclinical and toxicology laboratory inspection for GLP compliance
    

6. Data and facility auditing in both Greater China and US
    

7. In-process study phase inspection
    

8. Annual SOP reviews
    

9. Protocol reviews and final report audits
    

10. Establishment of GLP-compliant archives