Medical Writing & Regulatory
Biostatistics & Data Management
SUMMARY OF REGULATORY INSPECTIONS AND APPROVALS
AnaCipher CRO receives BE study approval from WHO in March 2020, through a desk assessment review process. The review process involved the Clinical & Bio-analytical phases of the study.
Indoco's CRO – AnaCipher receives EIR from USFDA
Indoco's Clinical Research Organisation receives zero 483s from USFDA
Indoco's CRO – ANACIPHER clears USFDA inspection with ZERO 483
Conducted internal training on “21 CFR Part 11” on 19th Jul 2019.
Conducted external training on “ICH-GCP” on 29th Jul 2019
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