Case Studies

Is there an Abbreviated Regulatory Pathway for our Combination Product in Korea, India, Taiwan, and China?

As the demand for quality healthcare in East Asian countries skyrockets, so does the potential for astronomical growth for the ...
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Regulatory Gap Analysis of Centrally Authorized (EMA) Biologics in the European Union

Introduction A subsidiary of a Fortune 100 company intended to introduce two pharmaceutical products used to catalyze healthy blood clotting ...
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How Would Change in Our Distributor Impact the Sale of Our Medical Devices in Taiwan?

Working with a distributor in the country of your target market is one of the most effective ways to quickly ...
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Assessment of why PMDA (Japan) may request Clinical Trial Data in some situations versus Clinical Evaluation Data for the same product

Introduction A large medical device manufacturer, faced one frustrating challenge while seeking approval for antimicrobial central venous catheters and antimicrobial ...
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