FDAlytics is an intelligent assistant platform to help in GXP

As major pharma companies in India continue to grapple with GMP compliance issues, a startup combining deep learning, AI tech, and NLP models based on artificial neural networks is helping subscribers be better prepared for inspections, learn from the US FDA trends and improve their GMP processes continuously based on those learnings. With the official launch planned for February 20, Bhavish Agarwal, Founder, FDAlytics.com tells Viveka Roychowdhury how his company's algorithms can augment the analysis of pharma regulatory affairs personnel by providing them up-to-date and readily available data points

- Viveka Roychowdhury

Bhavish, thanks for talking to Express Pharma. Tell us something about your previous life before you turned entrepreneur.

Thank you. It is my pleasure to speak to you. I have been working in the field of Artificial Intelligence (AI) for the last 10 years in companies such as Microsoft, Zlemma and Hired.com. I met my cofounder Chakri Uddaraju at Hired. He was working at Facebook building the Marketplace before we decided to start Fdalytics.com.

How did you find yourself starting an ML/AI startup for pharma companies in India after a career in Microsoft, etc?

It has been an interesting journey for us. We wanted to use our experience of working at big tech companies in cutting edge technologies in the field of healthcare and pharmaceuticals. During our interactions with multiple pharma players, we realized that GMP compliance remains one of the biggest and continuous challenges.

We identified the US FDA GMP regulation and compliance as the problem and started thinking about the various ways we can use our experience in deep learning and AI tech to solve this problem. We found two opportunities: First in terms of India’s growing position in the API and finished dosage exports to the US. By being in India, we are getting easy access to an industry which is looking out for innovative solutions to minimize or eliminate their compliance-related risks.

Secondly, once we started capturing the US FDA data, we immediately understood how ML/AL can become a big differentiator and create value for our customers.

In summary, strict monitoring of GMP laid down by the US FDA and vast amount of data where ML/AL can be used made it a no brainer for us to start an ML/AI company for pharma companies in India.

What is the basic rationale for FDAlytics.com? What are the features of FDAlytics.com like inspector analysis, etc?