Case Study

Global Regulatory Affairs

Global Regulatory Affairs

Pages 1 Pages

REVIEW. REVISE. RESULTS. GLOBAL REGULATORY AFFAIRS CASE STUDY A small biopharmaceutical company with limited late-stage expertise was getting ready to enter Phase III with a high-profile diabetes drug candidate. Before moving forward; however, the company asked Covance to evaluate their draft late-stage clinical development plan from a global regulatory strategy perspective. Understanding the Challenge ? Determining how to decrease the t

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