Caplin Point Lab’s CRO arm completes USFDA audit with ‘nil’ observations

New Delhi, Sept 24:
Drug firm Caplin Point Laboratories on Friday said the US health regulator has completed a virtual audit of its clinical research organisation division, Amaris Clinicals, and it ended with zero observations.
In a regulatory filing, Caplin Point Laboratories said Amaris Clinicals located at Chennai, has completed a virtual audit from United States Food and Drug Administration (USFDA) with ‘nil’ observations.
“It is an excellent milestone for our group, and shows our commitment to maintaining the highest standards of quality and compliance at all our units,” Caplin Point Laboratories Chairman C C Paarthipan said.
Amaris Clinical is capable of performing clinical studies for submissions to various regulators, Caplin Point Laboratories said in a regulatory filing.