Accutest Research Laboratories Pvt Ltd, the Mumbai based independent Contract Research Organisation (CRO), announced that the company has received its 21st approval for bio-study from US FDA. With this, the company claims that it has owned the largest number of FDA approvals as an Indian CRO.
The company has completed its expansion programme by the middle of this month. The facilities, which have undergone expansion, currently has a combined capacity of 190 beds and 16 LC-MS/MS including the API 5000, the most sensitive triple quadruple mass spectrometer for small molecule analysis in India, in addition to API -2000, 3000, 4000, Thermofinigans And Waters.
The capacity expansion programme will accelerate the company's momentum of growth, as it can handle more tests in the additional space with increased quality standards, according to the company officials. "Getting of 21 US FDA approvals is an indication of our commitment to Quality, Technology and Processes. It is the team work that has enabled us to achieve this honour," maintained Dr Satish Sawant, director and founder of Accutest India.
Accutest has recently launched an entirely new laboratory for the Formulation Development (F&D) at Mahape, Navi Mumbai. The lab has 16 scientists working in the team. The company has also tied up with Fuji Biomedix, a Japanese CRO, to cater to the needs of Japanese Pharma market.
So far, the company has conducted around 200 studies, out of which 88 submissions are to US FDA, 11 submissions to WHO, and 31submissions to EMEA (Europe), 8 Submissions to Anvisa (Brazil), 6 submissions to Canada and 44 submissions to other regulatory bodies. The company has three centres in India, at Mumbai, Pune and Ahmedabad each designed as independent CROs, with separate clinical processing unit, quality control & analytical unit, data processing cell, with a separate group of statisticians for each unit.
Accutest, which aims to become a "Total partner in drug development process" by 2010, is currently equipped to provide an array of services in BA/BE studies, phase I to phase IV clinical trials and formulation development with its facilities which has been successfully passed through audits by US FDA, WHO, Anvisa, EMEA, DCGI and MCC, added Satish.