Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 combined years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments.

Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia.

Mukesh is a trained specialist in technology transfer (licensing, negotiations, investment advise, product life cycle management, and commercialization issue resolution) and biotech business development. He is also active in developing and executing professional training courses, workshops, and symposia and is an Adjunct Professor at American University, Washington DC. Mukesh serves on the Board of Editors for the Regulatory Affairs Professionals Society's Focus magazine.

Our Panel of Honorary Advisors has been drawn from the fields of Clinical Practice and Research, Ayurvedic Teaching and Practice and Pharmacognosy and Medicinal Plant Chemistry all relevant areas to our business needs.

Prof. R. H. Singh | Prof. Asoke Banerji | Dr. Hemant K. Singh | Dr. C. I. Jolly

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