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My name is Dr. Mukesh Kumar and Herman Wong, but people call me Dr. Mukesh Kumar and Herman Wong. Here is my homepage: . I live in United States and work as an at ProfEdOnDemand.com.

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Dr. Mukesh Kumar and Herman Wong

Dr. Mukesh Kumar and Herman Wong

Pharma & Biotech

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. 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. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs  professional by the Regulatory Affairs Professional Society, USA. Read More

Herman Wong
is a Washington DC-based consultant for computer systems in FDA-regulated industry. He has been in the industry for over 12 years and leads the Information Technology department at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com).  His key expertise is in training of IT personnel in FDA-regulated industry, creating, managing and implementing Part 11 compliant computer systems. Since 2005, Mr. Wong has been evaluating EDC systems for  Part 11 compliance  at small and big organizations including some of the largest US federal organizations and large pharmaceutical companies. Read More

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