Dr. Lewis’ practice involves patent preparation and prosecution. Her patents focus on chemical, pharmaceutical, biological products and medical devices. She also provides regulatory compliance services from initial meetings with FDA to the preparation and submission of drug and device applications. Prior to attending law school, Susan acquired more than 10 years experience in global regulatory affairs and compliance addressing issues on behalf of various clients as they interfaced with the U.S. FDA and foreign regulatory authorities. Susan also served as a Lieutenant Commander with the United States Public Health Service and spent five years as a science officer assigned to the Food and Drug Administration reviewing new drug applications and performing pharmaceutical establishment inspections.

Susan’s background in international and domestic regulatory affairs makes her ideally suited to interact with client inventors as they develop new drugs and medical devices for which patent applications need to be prepared. Susan has consulted for numerous small start-up companies and larger pharmaceutical companies on regulatory filing strategy, ISO 9000 certification, pharmaceutical facility design and product development. Her recommendations save the client time and money in their design and product development time lines and facilitate a shorter time to government approval for commercial marketing.

Susan’s expertise in intellectual property law stems from her involvement with the Hatch Waxman Act which allows generic drug companies the opportunity to market drugs prior to expiration of the brand-named drug products’ patent term. She has been involved in several successful generic drug patent litigation cases and assisted in registering trademarks on pharmaceuticals.