Clients we represent include FDA-regulated industries such as clinical research facilities, and manufacturers, processors, and distributors of:

• Pharmaceuticals (both prescription and over-the-counter (OTC)), cosmetics and combination products
• Medical devices
• Small molecule and biologic/biotech drugs, both prescription and OTC, as well as cosmetics and combination products.

Our regulatory capabilities in these critical areas include pathway advice such as clinical trials, as well as regulatory and compliance issues relating to bulk and finished prescription and OTC drugs, approvals, advertising, marketing, and distribution. In addition to providing advice relative to FDA and Federal Trade Commission (FTC) implications of these products, we also have substantial experience in counterpart regulatory systems in the EU, Japan, Korea, China, and other markets.

Our product development and testing capabilities for this market include preparing pre-IND meeting requests, preparing for and leading pre-IND meetings between sponsors and FDA, and resolving issues that may arise in the IND process. FDA team members have specific experience in evaluating drug product formulations for conventional human and animal drugs, and the cell technology in biotechnology-produced drugs.  We assist with clinical research issues, informed consent matters, and review and approval with IRBs.

Team members also counsel intellectual property (IP) owners on strategies designed to maximize protection of a product or process idea. We work closely with the firm's IP attorneys to help transform an idea or young product into a commercial success, including the licensing or sale of IP assets. We also have extensive experience addressing issues that affect generic drugs, including FDA's "Orange Book," patent extension and marketing exclusivity, bioequivalence determinations and related competitive disputes, state formulary matters, and those that can arise with pharmacy and therapeutic committees.