About Us :

 
  Our Pharmaceutical Industry History

USA- New London, CT and Fort Lee, New Jersey 

FDASmart is a new company in the US and operated in India  as IIS Private Limited.

Back in 1994, our company in the USA (IIS Inc.) 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 under IIS Inc.

IIS Inc then established its wholly owned subsidiary in Mumbai-India as IIS Private Limited for the purpose of recruiting, screening, training and eventually sponsoring immigration/transfer of trained clinical IT development programmers/personnel to the US for Pfizer Central Research placements.

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.
   
Management

Ram Balani- Acting CEO- FDASmart Inc.

Our CEO is an experienced IT and Pharmaceutical industry professional with experience that includes outsourcing to the world's largest pharmaceutical company today-Pfizer Inc. in the US
Mr. Balani was privileged to work with Pfizer Central Research, Groton , CT in the 1990s when his company at the time was awarded a contract to create and seed a Clinical Data Management Support group for Central Research with Pfizer-India-Nariman Point.
He also served in a wide variety of roles in medical research laboratory technologies, laboratory IT (LIMS) automation, provided IT services in the US to other pharmaceutical heavy weights such as Glaxo Smith Kline (IT vendor company) and Forest Laboratories, etc.
He founded FDASmart last year 2007 when he discovered the dire need for bringing US FDA regulatory intelligence to the Indian pharmaceutical and biotech industry.
He successfully seeded FDASmart in India with a one year contract with ICRI-Institute for Clinical Research, India . (www.icriindia.com ). ICRI now bundles some of the FDASmart audio conferences for their Clinical Data Management Course Program being offered in Mumbai, Delhi, Ahmedabad and Bangalore campuses.
FDASmart Expert:

Dr. Joshua Sharlin - US FDA Regulatory Compliance Expert - Trainer/Consultant/Speaker (formerly a US FDA Drug Reviewer, Rockville, MD

Our partners are truly one of a kind.
Dr. Joshua Sharlin, Ph.D. for example, truly possess a unique blend of experience that is Hard to match.

Dr. Sharlin was:
 
1. Formerly a US FDA Drug Reviewer-CDER
2. Former Instructor on SAS at the SAS Institute, NC, US
3. Experienced Trainer/Consultant to the Pharmaceutical industry in the USA
   
He has trained well over 30000 students to date via his live audio conferences which often sell-out in the US
Further details on dr. Sharlin's background is below

Joshua Sharlin, Ph.D. Credentials

Summary:
Dr. Sharlin has practical hands-on experience in many aspects of drug and device development including; protocol development, regulatory affairs, design and execution of studies, data collection, data management, data reporting, data security, statistical analysis, software audits, software validation, technical writing, and finally FDA compliance and FDA evaluation for safety and efficacy. Expert in GCP regulations.

Highlights of Qualifications & Services

   
  FDA drug reviewer and FDA statistician
  Solve GCP compliance deficiency problems
  Developed solutions so patient registries met FDA compliance expectations
  Developed risk assessment procedures for data collection and information analysis
  Design databases for clinical trial information repositories
  Expert in design, execution & statistical analysis of clinical trials for drugs & devices
  Authority in 21 CFR Part 11 compliance and assessments
  Specialist in validation of computer systems
  Auditor of data management departments, CROs and software vendors
  Expert in developing strategies for reducing FDA approval time
  Technical writer, have written SOPs, documentation, study reports, etc.
  Taught validation, software development, Part 11 compliance and regulatory affairs to thousands of people from hundreds of pharmaceutical and medical device companies
FDASmart is actively seeking additional non-competing global talents for its operations and plans to sign up more experts from the US in the coming months.

Please do not hesitate to contact Ram Balani by email at rbalani@fdasmart.com or call FDASmart.

USA:
Office: 1-516-515-9642
Cell:        201-913-0558
India:
Office: 91-96196 61452