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In China, all the Clinical Research should be conducted in authorized institutions. Pharma-engine provides the GCP Training Service to help the institutions to meet the needs of SFDA.
Our services including:
- Policy/Regulation consultation
- relevant SOPs preparation/review
- Mock SFDA audit
- Personnel Training/GCP training
- On-site assessment
- On-site Clinical Investigator Audits
- In-house Central File Audits & System Audits
- Database Audits & Clinical Study Report Audits
- Clinical Laboratory Audits (Good Laboratory Practice [GLP] )
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