Independent consultant to pharmaceutical/biotech companies, venture capital firms, and hedge funds providing review (including due diligence reviews of potential new therapies in or initiating development), analysis and assistance in the assessment, development and execution of regulatory strategies and tactics in furtherance of the clients needs. Extensive experience, with Merck Research Labs, as the primary regulatory lead in the development, initial registration/approval and life cycle management of multiple drugs. Responsibilities also included providing regulatory due diligence input on potential acquisition, licensing and partnership opportunities. Experience in the regulatory aspects of the legal defense of Merck during tort litigation (in this case, related to VIOXX) that enables me to be a potential resource to attorneys engaged in such tort litigation.