Abstract

If trends continue, it is highly likely that regulatory professionals will become involved in one or more aspects of a due diligence process and be tasked with the identification of competitive intelligence. They will play a major role in evaluating risk-based transactions and competitive assessments which, for regulatory affairs professionals, consist of a determination of the actual product profile, likelihood of regulatory approval (with timing), and a determination of how that product profile (via the actual product labeling) stacks up against the competition.

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