Dr. Mukesh Kumar is a distinguished serial entrepreneur, senior executive, author, and sought-after thought leader with over 18 years of success in the global healthcare industry. As the founder of FDAMap and multiple other ventures, Dr. Kumar has earned a reputation as one of the world’s foremost experts in U.S. regulatory affairs, compliance, clinical trials, and innovative product development strategies.

His flagship company, FDAMap, has partnered with more than 1,100 clients worldwide, including several Fortune 100 and 500 companies in pharmaceuticals, biotech, medical devices, digital health, and broader healthcare sectors. Under his guidance, FDAMap has been instrumental in advancing over 100 medicinal and diagnostic products, coordinating more than 200 clinical trials, and managing thousands of regulatory submissions to the FDA, European Medicines Agency, and other global authorities. Dr. Kumar is recognized for his pioneering approach to disruptive product development, utilizing cutting-edge, cost-effective regulatory strategies that accelerate patient access.

Dr. Kumar also serves on the boards of several high-impact, innovation-driven companies, including Vivacelle Bio, Inc. (Kansas), ResQ Pharma, Inc. (Illinois), Kibow Pharmaceuticals, Inc.(Pennsylvania), Amarex Biosciences Pvt Ltd (New Delhi, India), and Pepfactor, Inc. (Sydney, Australia), where he provides strategic insights for growth and development.

In addition to his entrepreneurial ventures, Dr. Kumar is an esteemed author and thought leader.

His weekly blog, FDA Puran, reaches over 100,000 readers globally and covers critical insights into healthcare regulations. With over 800 published blogs and numerous articles in peer-reviewed journals, he is a trusted voice on both U.S. and international regulatory matters.

Dr. Kumar is also deeply committed to nurturing future talent. He created a Certificate in Clinical Project Management at Montgomery College in Maryland, where he trained hundreds of clinical research professionals over an 8-year period. Currently, he is a board member of the Montgomery County Economic Development Corporation and the lead trainer at FDAMap, delivering approximately 50 lectures annually on topics related to product development and entrepreneurship. Over the past 20 years, Dr. Kumar has trained more than 10,000 students and mentored over 100 emerging scientists, regulators, entrepreneurs, and policymakers, many of whom have gone on to become successful professionals in their fields.

Dr. Kumar holds a Ph.D. in Biochemistry, an MBA, a certified regulatory professional by the Regulatory Affairs Professionals Society (USA), a certified clinical trialist by the Bloomberg School of Public Health at Johns Hopkins University, and a Diplomate of the American Board of Regenerative Medicine. He is also a recognized compliance inspector and certifier.