Jim has extensive experience in government regulation of pharmaceutical, biotechnology, food, medical device and health care related companies.

His practice focuses on counseling such clients on complex regulatory strategies and compliance matters and representing clients in administrative and judicial enforcement actions and other proceedings involving the Food & Drug Administration (FDA), the Federal Trade Commission (FTC), the Drug Enforcement Administration (DEA), the Department of Justice (DOJ) and other federal and state agencies. In recommending Jim as a "Notable Practitioner," Chambers USA referred to his "impressive and well-reputed practice" (2011) and noted that sources praised him as "one of only a few people who really do think outside the box," the lawyer to turn to "if you are looking for innovation and someone to break new ground" (2010).

A particular emphasis of Jim's practice is navigating the myriad interrelated legal, regulatory and policy issues implicated by competitive pressures within the pharmaceutical industry. Chambers USA reports that clients praise "his ability to propose a creative solution" and characterize him as "practical, responsive and candid." Chambers further notes that he "brings significant FDA expertise to his work advising a range of clients on regulatory matters and he is well versed in representing clients in proceedings with government agencies" (2012). Jim is recognized as a leading authority on the Hatch-Waxman Amendments and the legal and regulatory strategies available to both innovator and generic drug companies. 

Jim's clients include a wide range of pharmaceutical, biotechnology, food and medical device companies, as well as banks, venture capitalists and other entities involved with life sciences companies. He guides these clients at all stages of a product’s lifecycle, from product development, marketing applications, advertising and promotional compliance, good manufacturing practices and post-approval safety requirements. He also counsels clients and performs regulatory due diligence in connection with financings, public offerings, mergers and acquisitions, licensing and joint venture agreements involving life sciences companies.