Welcome to FDASmart Inc.
FDASmart Inc. located in Amawalk, New York with Offices in Washington DC and India, is a US FDA pharmaceutical regulatory compliant (GCP /GMP) consulting and training company focused on assisting Asian markets. The Company is constantly monitors the latest US FDA regulatory mandates and policies in the pharmaceutical, biotech, biologics and medical devices industry.
Our unique value proposition is knowing how US FDA reviewers think and work ie our main Good Clinical Practice (GCP) expert and FDASmart President, Dr Joshua Sharlin was a former US FDA drug reviewer, has trained well over 35,000 with proprietary audio conferences and on-site training. Other GMP expert partners are world class US FDA compliant veteran professionals and most have done work in India.
Mission
Next to North America itself, the US FDA (Food and Drug Administration) grants more new drug approvals from clinical research trials done in India, i.e. more than than any other country outside of the USA.
This is both Exciting and Alarming at the same time !
India and China will soon emerge to be global clinical research & development outsourcing hubs. Yet, both countries are woefully native when it comes to integrating US FDA regulatory into the clinical R&D process.
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Why FDASmart
Our Unique Presence in the US and position in India:
FDASmart is a unique endeavor spawned initially out of a partnership between IIS Inc./IIS Private Limited and 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.
Dr. Josh Sharlin
As a Former US FDA reviewer, I bring to FDASmart expert compliance and submission know how
Services
FDASmart offers a number of products and services all designed train and guide pharmaceutical companies in the
complex and arduous path to drug discovery and clinical research studies as it RELATES TO US FDA regulatory
compliance.
We do this a number of ways:
(a) Live Audio Conferences/Training delivered from the US
This is a proven and time tested economical way to train pharmaceutical and CRO companies.
These live audio conferences are conducted by Dr. Joshua Sharlin personally for 90 minutes. 30 minutes
thereafter is allotted for Q&A. Dr. Sharlin has authored around 30 topics and has trained well over 30000 students in
US and Europe over the last few years. A list of the live audio conferences and a brief description are included
below.