Seth works with clients to develop and implement premarket strategies and product approvals and handles matters involving postmarket compliance and enforcement defense. His work covers FDA-regulated industries including pharmaceuticals, medical devices, biotechnology, food, dietary supplements, cosmetics, tobacco, and emerging areas such as digital health, cannabidiol, psychedelics, artificial intelligence, and cybersecurity. Seth regularly guides clients through medical device premarket submissions, including Premarket Notifications [510(k)s], Premarket Approvals (PMAs), and Investigational Device Exemptions (IDE), as well as pharmaceutical submissions, such as New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDA), and Investigational New Drug exemptions (INDs). Seth helps clients with business-focused labeling and promotional reviews, including those requiring USDA review; good manufacturing practice (GMP) and quality system compliance; adverse event reporting; and imports. He also supports clients during inspections and audits, manages product recalls, and represents them in enforcement matters involving state regulators, the FDA and U.S. Department of Justice, among other agencies.

Seth’s background as a chemical engineer and more than a decade of service at the FDA—as an investigator, compliance officer, and regulatory researcher — gives him uncommon insight into how the agency operates and what regulators expect. He brings that perspective to bear in a wide range of matters, including government investigations, litigation support, and corporate transactions involving FDA-regulated businesses. His practice also includes advising on other technical regulatory areas, including state Extended Producer Responsibility (EPR) requirements, restrictions on per- and polyfluoroalkyl substances (PFAS), California’s Proposition 65, and preemption of state consumer protection laws, such as California’s Consumers Legal Remedies Act (CLRA), False Advertising Law (FAL), and Unfair Competition Law (UCL), when used to attempt to enforce federal labeling requirements.

Seth also works on corporate matters involving regulatory topics, such as clinical trial agreements, quality agreements, pharmaceutical co-development and licensing agreements, U.S. Securities and Exchange Commission (SEC) filings detailing FDA milestones, and regulatory due diligence for mergers, acquisitions, and public offerings. Whether helping companies bring products to market or respond to urgent compliance issues, Seth is known for his ability to combine deep technical fluency with practical, business-minded advice.