2024-2025 Global AI Trends Guide
Bert Lao
Counsel Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
Bert Lao helps drug companies get their products on the market, keep their products on market, and stay in compliance with their regulatory requirements. Whether you’re a major pharmaceutical company, a startup looking to get your first approval, or a cutting-edge tissue engineering or gene therapy company, Bert has advised clients at every stage of the product development process, from conducting clinical trials, to meeting with FDA, to submitting an application for FDA approval.
Beyond product development, Bert also helps drug companies maintain regulatory compliance and fight legal challenges. Bert has assisted clients with preparing securities filings, conducting internal investigations, drafting trade complaint letters, and reviewing advertising and promotional materials for prescription drugs, over-the counter drugs, and cosmetics.
With over ten years of experience practicing pharmaceutical law, Bert stands ready to help you navigate one of the most heavily regulated industries in the United States.
Representative experience
Assisted companies with FDA submissions, including citizen petitions, dispute resolution requests, requests for designation, and designation requests for orphan drugs and rare pediatric diseases
Assisted companies with the development and marketing of over-the-counter products under FDA’s monograph system
Drafted trade complaint letters to FDA on behalf of clients advocating for regulatory enforcement actions
Assisted a pharmaceutical company with an internal investigation regarding its regulatory reporting and public disclosure requirements
Credentials
Education
- J.D., University of California, Berkeley School of Law, 2011
- Ph.D., University of California, Los Angeles, 2008
- B.S., University of California, San Diego, 2003
Bar admissions and qualifications
- California
Court admissions
- Supreme Court of California