The six-month old Chennai-based Clinical Research Organization (CRO) Quest Life Sciences has entered into a Memorandum of Understanding (MoU) with the Brazilian pharma major EMS Sigma Pharma to undertake evaluation studies of their potential pharmaceutical products.
As per the agreement, Quest would conduct 15 evaluation studies in a year, and the order is valued about Rs 2.5 crore. The order is the first of its kind from Brazil for an Indian CRO.
The Brazilian regulatory body Agency National for Vigilance Sanitaire (ANVISA) recently had inspected Quest Life Sciences following the move of the Brazilian pharma major to entrust evaluation studies to 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.
Incidentally, Quest is also the first Indian CRO to bag direct orders from any US pharmaceutical companies for clinical trials and bio-analytical services and support in India. As reported in Pharmabiz earlier, Quest had undertaken evaluation studies of two US companies, Tishcon Corporation, a mid-sized nutraceutical and vitamin manufacturing company and the New Jersey-based Vista Pharmaceuticals, for a few products coming off-patent.
According to T S Jaishankar, managing director, apart from the Brazilian order, ten top Indian companies have evaluated Quest and many orders are in the pipeline. Similarly, a few orders are in the pipeline from Thailand. In the six-month period, Quest has completed about 15 studies.
Located at the Madras Export Processing Zone, Quest Life Sciences is a 50:50 joint venture between Jaishankar 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. The facility has a current capacity for 30 studies per month, and about 250 to 300 studies in a year. Quest also has a US office in Indianapolis, USA, headed by Dr. Banakar, the chairman of the company.