Last Updated on December 31, 2023 by The Health Master
Indoco Remedies’ Clinical Research Organisation (CRO), AnaCipher, today cleared the US Food and Drug Administration’s (USFDA) inspection.
The CRO, located in Hyderabad, was inspected by the USFDA from 12th to 16th September 2022.
The clinical phase of inspection covered three BA/BE studies submitted by clients to the USFDA and was successfully concluded with zero 483s.
“This is the seventh successive USFDA inspection with zero 483s for AnaCipher CRO.”
In the statement, “We are committed to strict adherence to all applicable guidelines and regulations and maintaining the highest quality standards in delivering quality services to our clients,” said Aditi Kare Panandikar, Managing Director, Indoco Remedies.
Further, according to the statement, the CRO also has expertise in bioanalytical work for new chemical entities (phase I-III studies) for pharma companies globally.
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