Mukesh Kumar, RAC, PhD

I started my career as a staff scientist at NIH, working in basic biology and applied science in gene therapy. After patenting some of my inventions, I trained in intellectual property and licensing processes where I realized the importance of regulatory affairs in biomedical products. My next job, managing more than 50 global clinical trials sponsored by US govt, helped be gain experience in global regulatory processes. My current job involves working with mostly small companies for product development strategies all the way from preclinical to clinical and post-approval turning me into a medical product professional with holistic experience in developing therapeutic and diagnostic product. Currently I am working towards bringing therapies developed in Asia and Latin America to the US and EU.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits. Articles written by me can be found at http://www.amarexcro.com/articles/