Fdasmart Inc. New York

Usa- new london, ct and fort lee, new jersey back in 1994, our company in the usa was established as a 3rd party vendor to pfizer central research, groton, ct. We gained tremendous understanding of pfizer pre-clinical and clinical work environment and culture. In time that know-how gained of the pfizer business process by our founder ram balani from his presence in central research- groton connecticut in the us was leveraged to create a 3rd party clinical it development group for pfizer in mumbai-india. Rolling forward some 10 plus years and more in time, it is evident that the pharmaceutical industry in india has matured significantly. The passage of the patent product act in 2005 by india government was a significant milestone that will surely help drive india into the global driver seat for clinical research outsourcing via cros, smo, local indian pharmaceutical and device manufacturing companies, biotechs, etc. After some significant business and industry due diligence, we observed that there is today ample business opportunities in the clinical research training arena. Digging further into the indian pharmaceutical scene, we discovered that within training for clinical research, compliance with us fda regulatory understanding was sorely lacking and therein lies plenty of opportunities. In india today, there is significant lack of us fda regulatory compliance know-how and understanding vitally needed by the indian domestic pharma industry to address a global us market for drugs discovered and developed in india. It was evident to us that india needs 'work' to get to globally acceptable clinical trials/ drug development process mandated in the us by the us fda.