Regulatory Affairs in an Entrepreneurial Environment
RGA6218 / 4 q.h.
In a small or start-up company, the successful translation of discoveries from the bench to the market presents challenges shared by both the entrepreneur and the regulatory professional. Since investors and prospective corporate partners view regulatory requirements a potential market barrier, it is crucial that the regulatory professional be able to demonstrate how the regulatory environment is conducive to a product’s development and commercial success. Through case studies and group projects, students are given an opportunity to develop regulatory strategies tailored to the characteristics of small and start-up companies. Topics include developing a quality system from the ground-up, assuring on-going compliance with a minimum of resources, informing venture capital of regulatory hurdles, and employing regulatory considerations to create a sustainable competitive advantage.
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