The Brazilian regulatory body Agency National for Vigilance Sanitaire (ANVISA) is likely to inspect the recently started Chennai-based Contract Research Organization Quest Life Sciences shortly following the move of a leading Brazilian pharmaceutical company to entrust evaluation studies with Quest.
As per the ANVISA norms, it is mandatory for all CROs to be pre-approved and accredited before any study is conducted for Brazilian submission.
Talking to Pharmabiz, T S Jaishankar, managing director of Quest Life Sciences said the audit team of the Brazilian company was in Chennai this week, and this order was likely to catapult the performance of Quest, started just three months ago.
Already five leading Indian companies have agreed to entrust evaluation studies with Quest, and out of this, two companies have submitted details to the US FDA. Quest has also fully automated its various divisions, including finger printing.
Quest, claimed to be first Indian CRO to bag direct orders from any US pharmaceutical companies for clinical trials and bio-analytical services and support in India, had recently completed two way cross over pivotal study with 24+2 volunteers for two US firms. The study was for a few novel products of Tishcon Corporation, a mid-sized nutraceutical and vitamin manufacturing company, and for the New Jersey-based Vista Pharmaceuticals, for a few products coming off patent.
Located at the Madras Export Processing Zone, Quest Life Sciences is a 50:50 joint venture between Jaishankar's Chemech Laboratories Ltd., and Prof. Umesh V Banakar, the US-based world-renowned pharma consultant and academician.
The company offers quality clinical, bio-analytical and data management support to facilitate the international introduction of generic products, research on novel drug delivery systems and clinical development of new chemical entities as per GCP, GLP standards laid down by ICH/WHO/FDA.