Case Study

Global Regulatory Affairs Strategy

Global Regulatory Affairs Strategy

Pages 1 Pages

Optimizing Opportunities by Leveraging the Regulatory Environment: Global Regulatory Affairs Strategy Case Study A Korean pharmaceutical company was looking to develop a transdermal patch for an already approved and established oral drug for Parkinson’s disease and Restless Leg Syndrome. Marketing approval of their patch was sought in Europe and the Asia Pacific region. Understanding the Challenge ? Leveraging existing data from the initia

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