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Jonathan Trinh specializes in FDA regulatory matters involving drug, medical device, and combination products. Jonathan advises innovative life sciences companies navigate 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 expertise on transactional matters and white-collar criminal defense matters involving FDA-regulated products and entities. He is a frequent author and presenter on emerging issues affecting the life sciences industry.
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 MLR Review Committee to help develop commercial strategies for launching a first-in-class rare disease drug product;
- Conducting due diligence evaluations 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.
Jonathan is a champion for diversity and inclusion, mentorship, and pro bono initiatives. Jonathan actively participates in K&S's Diverse Retreat Planning Committee, K&S's Asian American and LGBTQ+ Affinity Groups, and bar associations and non-profit organizations committed to the professional development of diverse lawyers. He represents K&S at diversity conferences and on-campus events to recruit rising leaders in the legal profession. He also maintains an active pro bono practice providing robust legal representation for undocumented individuals and LGBTQ+ individuals.
Jonathan graduated from the George Washington University Law School with a concentration in health law. During law school, he served as Editor-in-Chief of the Federal Circuit Bar Journal, President of the Asian Pacific American Law Students Association, and Vice President of the Student Health Law Association. He also interned for the Hon. Rudolph Contreras at the U.S. District Court for the District of Columbia.
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