Jonathan Trinh is an associate in Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where he focuses on FDA regulatory matters involving drugs, medical devices, combination products, and artificial intelligence and machine learning. Jonathan advises start-ups and emerging life sciences companies on navigating pre- and post-market challenges throughout their products’ lifecycles, enabling them to launch and commercialize their products in the U.S. Jonathan also applies his regulatory knowledge to transactional matters and white-collar criminal defense matters involving FDA-regulated products and entities.

Jonathan’s representative experience includes:

• Drafting regulatory submissions (e.g., pre-submissions, 513(g) requests, etc.) to inform companies’ go-to-market strategies;
• Serving on a pharmaceutical company’s Medical, Legal, and Regulatory Review Committee to help develop commercial strategies for launching a first-in-class rare disease drug product;
• Conducting due diligence assessments to advise investors on potential regulatory and enforcement risks of target companies in multi-billion-dollar mergers, acquisitions, and licensing agreements;
• Performing internal investigations, overseeing remediation activities, and preparing reports to C-level executives, FDA, and DOJ to mitigate regulatory and enforcement risks; and
• Developing and implementing compliance policies for life sciences companies to reflect current federal and state laws, and industry codes of conduct.

Prior to joining the firm, Jonathan was an associate with a top-ranked FDA and life sciences practice of a global law firm. Before that, he interned for the Honorable Rudolph Contreras at the U.S. District Court for the District of Columbia.