Why FDASmart ?:

Our Unique Presence in the US and position in India:

FDASmart is a unique endeavor spawned initially out of a partnership with Dr. Joshua Sharlin in the United States.

The pharmaceutical industry in India has grown tremendously since 2005 when the Product Patent Agreement was signed and now being enforced by the government of India.

Today-it is estimated that new drug development costs upwards of a $ 1 Billion USD and takes well over 10 years or more of research and development in the US. Cheaper labor costs, ample skilled human manpower and an adequated medical clinic/hospital infrastructure plus a large supply of treatment native patient pool for clinical research studies has CONVINCED the US pharma industry to look to India for outsourcing new drug development.

US and European based pharmaceutical companies now see outsourcing clinical trials to Asia as mission critical.

FDASmart has chosen to fill an unmet need as result of these industry trends. With its roots in the US and network of pharma HIGHLY qualified experts and industry relationships, FDASmart in uniquely positioned to BRIDGE THE GAP of bringing US FDA regulatory smarts to INDIA.

Our mission in India is clear we intend to deliver to the Indian pharmaceutical and CRO industry and other related stakeholders what we feel is a weak link in the global clinical trial outsourcing phenomena, i.e. US FDA regulatory compliance and training.

Strategic Partnership / Alliance between FDASmart and ICRI-India-Sri Lanka, Dubai and Singapore

On December 2007, FDASmart signed an Exclusive Agreement with ICRI (Institute for Clinical Research-India), India's largest and leading clinical research training institute.

ICRI is the premier clinical research institute in India and is following an aggressive global expansion policy which over the next two years which will see a presence in UK, Singapore, USA, Dubai, Sri Lanka and China.

ICRI currently has in excess of 2000 students following the following programmes in its four campuses in Ahmedabad, Bangalore, Delhi and Mumbai with further centres planned over the next 12 months in Pune, Hyderabad, Chennai and Kolkata:

ICRI has chosen to bundle a give number of the FDASmart live audio conference training topics into their Clinical Data Management programs. This will be delivered to ICRI students from the US via live audio conferencing to enrolled students at Mumbai, Delhi, Bangalore and Ahmedabad ICRI campuses.