Leadership
At FDAMap Clinical, our leadership team is dedicated to advancing clinical research, regulatory compliance, and quality assurance through strategic expertise, global experience, and innovative trial management solutions. Led by renowned industry professionals, we provide trusted guidance to pharmaceutical, biotech, and medical device companies in achieving regulatory success and clinical trial excellence.
Dr. Mukesh Kumar, PhD, RAC
CEO and Founder, FDAMap Clinical
Dr. Mukesh Kumar is the CEO and Founder of FDAMap, a Washington, DC-based firm that specializes in regulatory affairs, quality assurance, clinical trials, and smart development strategies for FDA-regulated products. With a career spanning over two decades, Dr. Kumar has played a pivotal role in global regulatory project management, clinical trial operations, and compliance inspections for medicinal and diagnostic products.
Global Experience in Clinical Trials & Regulatory Affairs
- Led the clinical development of over 100 pharmaceutical and medical device products.
- Managed 150+ clinical trials across 34 countries, including the EU, Taiwan, Korea, Japan, China, Canada, South America, Australia, and India.
- Conducted 100+ audits for GCP, GLP, GMP, and GACP compliance across North America, Europe, and Asia.
- Provided regulatory consultation for FDA, EMA, and global health agencies.
Industry Thought Leadership & Contributions
- Published numerous peer-reviewed articles on clinical research and FDA compliance.
- Conducted hundreds of regulatory training workshops for industry professionals.
- Writes the widely-followed blog, FDA Puran, with over 80,000 global subscribers.
- Serves as Adjunct Professor of Regulatory Sciences at George Washington University, School of Medicine.
Dr. Kumar holds a PhD in Biochemistry and is a certified regulatory professional by the Regulatory Affairs Professionals Society (RAPS), USA. His deep industry knowledge and global regulatory experience make him a trusted advisor for companies navigating clinical trials and FDA approval processes.