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Putting a product back into play . . .

The Clinical Pharmacology & Biopharmaceutics Service Area has experience with bioequivalence and pharmacokinetic issues related to generic drugs. This can be particularly useful to companies who are unfamiliar with Abbreviated New Drug Applications (ANDAs) and 505 (b)(2) New Drug Application (NDA) regulatory requirements. We will work with clients who are seeking a new route of administration for a drug, and need to attract investors. We provide them with a strategy, a critique of their development plan and a cost analysis that gives them a clear and actionable picture of their product’s market viability.

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