Dr. Mukesh Kumar is CEO and Founder of FDAMap, a Washington DC-based firm helping manufacturers and developers of FDA-regulated products in regulatory affairs, quality assurance, clinical trials and smart development strategies. His key expertise is in global regulatory project management, regulatory submissions, compliance inspections, operational management, supply management, clinical operations, and multi-national project management for medicinal and diagnostic products. He has led clinical development of more than 100 products over the last 20 years.

He has been a leader in more than 150 clinical trials in about 34 countries including countries in the EU, Taiwan, Korea, Japan, China, Canada, countries in South America, Australia, and India.  He has led more than 100 GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia in the last 15 years. He has conducted numerous training workshops in FDA compliance related issues and has authored numerous articles in peer-reviewed journals.

 His weekly blog, FDA Puran, is subscribed by over 80,000 readers globally. He is also the Professor (Adjunct), Regulatory Sciences, at the School of Medicine, George Washington University, Washington DC. Dr. Kumar is a PhD in Biochemistry and a certified regulatory professional by the Regulatory Affairs Professionals Society, USA.