Interview

'Our mission is to de-mystify the US FDA so they become your partner and not an adversary'

\With India becoming strictly schedule M compliant and companies looking for upgrading their facilities, there is a new player in the market FDASmart, who with its technologies and audio conferences promises to deliver the best regulatory expertise. Ram Balani, CEO, FDASmart speaks about the company and deals at hand, with Arshiya Khan

What is FDASmart all about? How does the concept work?

FDASmart delivers US FDA pharmaceutical regulatory compliant 'smarts' globally specialising in emerging regions like Asia and Latin America. Our mission is to de-mystify the US FDA so they become your partner and not an adversary.

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.

What are your offerings for pharma and biotech industry?

FDASmart offers US FDA (soon UK MHRA) pharma compliant training and consulting. With SmartInspect, FDASmart's wireless, mobile and wearable conferencing technology, FDASmart can now 'deliver' our US and UK regulatory experts without the enormous travel and time costs of overseas travel.

What is the price difference between opting for a FDASmart audio conference over a full time course?

With audio conferences, costs can be better managed without compromising world class quality. We price by the sessions or modules not the number of participants.

For GMP training, using our two-tiered strategy coupled with SmartInspect technology, our prices are somewhat higher than customary India pricing but we deliver premium world class resources available from the US, here in India with no compromises on global standards and know-how.

What is the frequency of each course?

Course frequency varies depending on the whether they are delivered on-site India or via the internet or with our exclusive SmartInspect technology (for GMP).

Audio conferences are two hours each with 30 minutes Q&A. Written handouts and SOPs for selected courses are sent to the students ahead of time.

Please elaborate on the training module adopted at FDASmart?

We started with audio conferences delivered from Washington DC via Skype to cut costs for GCP regulatory courses/topics. For GMP we are introducing a first of a kind two-phase training which will be delivered by our Indian trainers coupled with our Western experts via SmartInspect.

What about certifications and accreditations?

After student testing, we jointly provided with ICRI a US FDA Understanding Completion Certificate.

How is the business performing?

We are gaining more and more market awareness in India as a best of breed training source with world class standards plus as a pharma supply chain technology solutions provider.

Last year we had an exclusive partnership with ICRI, which has now concluded. Apart from Indian pharma and MNCs, we are beginning to license our training materials with other trainers and institutes.

SmartInspect business is growing. It is a technology which can assist pharma and biotech companies manage supply chain as it relates to. For example- monitoring/policing quality audits of API sourcing from emerging countries like India and China or for bio partnering regulatory compliance.

Pfizer in the US, world's largest pharma company is a SmartInspect customer. It has purchased our SmartInspect system to assist them with auditing quality from API sources in emerging countries.

Sanofi Aventis and Glaxo SmithKline both in the US also are evaluating SmartInspect for off-site training and possible tool to assist bioresearch monitoring of GCP compliance at their clinical trial sites globally located. Three of the top ten global pharma companies have expressed interest.

Tell us about the deals at hand?

We deliver US FDA understanding audio conferences to training institutes including ICRI, India's premier and largest clinical research training institute for their MSc and PGD (Post Graduate Diploma) CRA training programmes.

We are negotiating currently with India's leading life sciences/IT company to develop custom training designed and delivered by Dr Sharlin. Several licensing and partnership talks are happening with other companies and training entrepreneurs.

Which markets are you targeting at?

We will focus on emerging countries starting with India and soon other regions in Asia. India is unique with the fact that outside of the US, India has the largest number of US FDA approved manufacturing following the GMP (Good Manufacturing Practice) standard.

What are your plans for the Indian market?

We are planning to create India's first dedicated global pharma training institute to be implemented with our 2-tier strategy, i.e. using Indian training expert talents screened, qualified, trained and monitored for quality by our Western experts. Soon we will add UK MHRA, Australia TGA, Brazil ANVISA, etc.

We have introduced SmartInspect in India at the recent Bangalore Bio 2009 as well and have received a very positive response.

How do you see this concept gaining pace?

We expect to grow rapidly since India is 'hungry' for global class pharma know-how unlike China today. India observes ICH GMP manufacturing compliance for instance which is close to the US FDA standard.

What are your expansion plans?

We plan to leverage our competitive advantage via the two-tiered training strategy using SmartInspect when appropriate.

Managing the pharma supply chain is job number one for most big pharma and with the global markets including the US and Japan clamouring for more and more generics from India, the future looks bright I would say.

arshiya.khan@expressindia.com