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Regulatory Exclusivities, Hatch-Waxman, and Similar Statutes

Successfully bringing a product to market requires a strategic approach that encompasses scientific, legal, regulatory, and commercial considerations. That’s what we help our clients do, with a particular focus on approval standards, regulatory exclusivities, and patent protections.

We know the law and regulations in detail, but not at the expense of the big picture, and we understand how FDA works. Our goal is to help develop and implement strategies that allow companies to successfully operate in a highly regulated and competitive world.


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