PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research
Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). Mr. Kumar’s key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA.
In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.
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