We provide the regulatory scientific support needed to advance a manufacturer’s products through the premarket approval regimen of the FDA and its European counterparts. Our practice includes a number of doctoral and post-doctoral professionals with pharmaceutical and medical device backgrounds. They are further aided by chemists, toxicologists, pharmacologists, electrical engineers, mechanical engineers, physicists, and specialists in other pharmaceutical- and device-related disciplines from around the firm. These individuals enhance our ability to provide manufacturers with sophisticated advice concerning the scientific aspects involved in FDA regulation of their products, and to resolve scientifically oriented legal issues.
For example, we advise and assist manufacturers in preparing and filing the full range of product submissions, including Investigational New Drug Applications, Investigational Device Exemptions, New Drug Applications and supplements, Premarket Approval Applications and supplements, panel reviews, 510(k) premarket notification submissions and modifications, Orphan Drug designation requests, food additive petitions and GRAS notices, dietary ingredient and 30-day market claim notices, and citizens’ petitions. Our scientific expertise enables us to advise on whether and what type of product submission is necessary, including whether product modifications, material and related changes trigger new product filings. We also assist in the development of breakthrough products, including clinical trial design, in a wide variety of medical fields. Our scientitists, together with our legal staff, provide significant assistance in preparing product-specific scientific presentations to FDA and related governmental agencies. For example, our scientists prepare peer-review-quality scientific advocacy White Papers for use in regulatory and legislative matters, such as dispute resolution, jurisdictional determination, and congressional appropriations. Our scientists also provide toxic tort litigation support, and interact with medical and other scientific experts.