Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet the Expert: Anchal Choudhuri, Vice President, Medical Devices, U.S. Regulatory
Located in: Washington, DC
What is one lesson you’ve learned in this industry that has most helped you?
That you have to balance speed-to-market with delivering a high-quality product. At the end of the day nobody wants to get a disapproval letter from the FDA or get approved only to face product recalls. Knowing how much data to generate, when and how to submit that data to the FDA, and/or when a design change is needed all factor into that delicate balance that we aim to help our clients achieve.
What do you like best about working with clients?
I love being able to share my expertise to help our clients succeed. It’s great to feel like a part of the client team and assist as they go through the regulatory process. I also enjoy the diversity of products and clients we have and being a part of a project from product development to clinical trials to being on the market.
What is a current trend you’re seeing in the industry that impacts our clients?
The collection and use of patient centered and digital data, such as from mobile apps or wearables continues to grow. More clients are including mobile apps as part of their medical device or combination product, and we have helped them to determine whether or not their app is regulated as a device (or device constituent part) and to understand the requirements for regulated apps. The use of such data in clinical trials is also growing and requires unique consideration.
How do you support ProPharma Group’s mission and higher purpose of improving the health and safety of patients?
I help get products to market. By providing regulatory science expertise to our clients, I help small companies achieve their big dream of making their unique medical product available to patients in the US.
Tell us a little bit about yourself outside of work.
I’ve lived in the suburbs of Washington, D.C. in Maryland most of my life and am somehow still finding new places to explore in the area. Outside of work I primarily enjoy spending time with my friends and immediate and extended family, most of whom live close by. I also enjoy hiking, cooking, yoga, and binging shows on Netflix (I can never watch just one episode of anything).
In your opinion, what value does a client gain by working with ProPharma Group’s regulatory experts?
Our regulatory experts are called experts for a reason! We have a great team, each with a strong background in and understanding of a particular area pertaining to product approvals and compliance across the globe. Our regulatory experts are all extremely hard-working and dedicated to helping our clients.
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