Dr. Mukesh Kumar

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Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of pharma and biotech products. He has been involved in more than 100 multi-national clinical trials, has made hundreds of submissions to the US FDA, EMA, and regulators in more than 40 countries.

Investigator’s Brochure (IB)

FDA Rules for the Content, Tone and Format of an Investigator’s Brochure

Investigator’s Brochure template is provided to attendees. An Investigator’s Brochure (IB) is perhaps one of the most important…

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