Last Updated on September 27, 2021 by The Health Master
Amaris Clinicals, the clinical research organization (CRO) division of Caplin Point Laboratories Limited, located at Chennai, has completed a virtual audit from United States Food and Drug Administration (USFDA) with NIL observations.
Chairman C. C. Paarthipan commented “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.
In addition to being a profit centre on its own in the coming years, Amaris will facilitate cost effective and quicker foray into newer geographies we plan to expand, where BA/BE studies are required for product approvals.
Considering the potential increase in demand for these activities, we will be expanding capacities at this site shortly.”
The company targets approvals on mutual recognition basis from other regulatory bodies, including ones from Latin America, a key geography for Caplin Point.
Amaris Clinical is a highly automated state of the art clinical research organization capable of performing clinical studies for submissions with various Regulators like USFDA, EMA, WHO, TGA, ANVISA, etc.