Practice Areas

Regulatory Compliance

Many pharmaceutical and biotechnological products and medical devices are subject to regulation by the U.S. Food and Drug Administration and similar foreign regulatory authorities. Exclusive marketing rights, distinct from patent rights, may protect or prohibit the marketing of such products and devices. Companies intending to develop and market such products should consult with legal counsel and appropriate clinical research organizations (CRO) to help them understand the web of related laws and regulations. Our attorneys have experience working together with CROs to assist in the early stages of product planning and development. Likewise, our attorneys are experienced in adversarial proceedings, such as Hatch-Waxman litigation and challenges to marketing authorizations granted by EU member countries.