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Minh-Duc Nguyen

Senior International FDA Regulatory Advisor

main: +1 (858) 869-1250

Minh-Duc Nguyen is an FDA Regulatory and Quality Consultant affiliated with Torrey Pines Law Group, bringing over 20 years of experience guiding medical device, pharmaceutical, and biotech companies through complex regulatory landscapes. He specializes in building robust Quality Management Systems (QMS) that accelerate time-to-market while consistently passing FDA inspections.

At Torrey Pines Law Group, Minh-Duc supports drug and device development companies with end-to-end Quality Assurance (QA) and Quality Control (QC) services, ensuring full compliance with FDA regulations across the product lifecycle—from registration and manufacturing to reliability testing, quality audits, and enforcement response.

≡
  • Meet Our Team
  • Randy Berholtz, MLitt, MBA, JD
  • Robert Buchanan, PhD, JD
  • Kevin Buckley, JD
  • Doranne Frano, MS, MBA
  • James McFarland, JD
  • Eleanor Musick, JD
  • Shihong Nicolaou, PhD
  • Minh-Duc Nguyen
  • Daniel Park
  • Milan Shah
  • Jake Siciliano, JD
  • Steven Stupp, PhD
  • Fawn Zhang, PharmD, JD
  •  
  • Administration
  • Carina Collins
  • Ben Irvin, CPA
  • Irene Keselman
  • Diana Monge
  • Amy Stedman
  • Anelynn van Gosliga
  • Cyndi Willis
  •  
  • Foreign Associates

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Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.

We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.