“You can have all the technical knowledge and expertise, but you have
to care about the lives you’re touching. That’s why we do what we do.”
As the founder, president, and CEO of Jeff Yuen & Associates, Inc., with over 32 years of compliance and regulatory experience, Jeff Yuen is widely recognized as a CGMP and compliance expert by both the industry and FDA's Office of Compliance. It is well-earned respect for the leader of an FDA regulatory and compliance consulting firm with a 24-year record of helping biotech and pharma clients prepare medical devices, pharmaceuticals, and biologics with nearly a 100% “first time” PAI success rate with respect to CGMP. Yet driving JYA’s extraordinary record is not professional ambition, or profits, or industry status. Rather, the values of a leader who has devoted his entire career to the welfare of others—as a peace officer/investigator with the State of California, Food and Drug Branch and a CSO for the FDA, then as Commander with the U.S. Public Health Service, with numerous PHS commendations and achievement medals, including Vice President Al Gore’s Hammer Award for leadership in the areas of innovative biotechnology and industry outreach programs.
This is the story of the convergence of education, career, family, and faith that led Jeff to establish one of the world’s most well-respected consulting firms for the pharmaceutical and biological industries, driven by their unwavering values to serve the greater good. “We look at both our clients and the patients whose lives we touch,” Jeff says. “You can have all the technical knowledge and expertise, but more than anything, you have to care about the lives you’re touching. That’s why we do what we do.”
Jeff Yuen & Associates, Inc.—Bringing Life-Changing Medical Devices and Drugs to Market Faster to Help People Sooner
Founded in 1998, JYA works with biotech and pharma clients worldwide to ensure successful FDA inspections and to resolve their FDA regulatory and compliance issues. The firm is purpose-built with 50/50 FDA and industry experts—comprised of former FDA national experts, specialists, supervisors, consumer safety officers, compliance officers, microbiologists, chemists, and center personnel, and complemented with former industry quality, compliance, operations, and regulatory affairs experts. JYA specializes in sterile and non-sterile dosage forms, small and large molecule products, vaccines, medical device, combination products, cell and gene therapy products, and provides Sterility Assurance expertise.
As Jeff leads the growth of JYA to serve the swell of new medical research, discoveries, and drugs by both Big Pharma and startups alike, he now embarks on a bigger mission. “This last chapter of my career will be devoted to giving back to charitable causes to fulfill my duty as a person, a leader, and a Christian,” he shares.
We spoke with Jeff to hear more about JYA and their expansion efforts, and the story of how the hand of Providence delivered him on a lifelong mission to serve the greater good.
Where does your passion for medicine and public health come from and how did it lead to JYA?
My dad. He was a surgeon, and as a kid, I’d do rounds with him. By my teens, I knew I wanted to follow in his footsteps. I’m also a Christian with a deep-rooted belief that God opens and closes doors for a reason. I was denied 38 times for med school, yet got into the public health program on my first attempt. God closed the medical school door intentionally to open the public health door for me to serve the greater good in my roles in government service, health departments, a peace officer for the FDA, and then for the federal FDA, which ultimately converged into JYA. I always used to tease my dad that he had his patients, but I had the world, serving communities and countries.
Tell us a little more about JYA and why this work is so important to you.
JYA is a public health organization that provides important regulatory and compliance consultation to pharmaceutical, medical device, biotech, and biologics companies seeking FDA approval and/or commercialization of medical products in support of patients with unmet medical needs. Our work reflects our inherent passion for enabling people access to a better life and good health free from the burden of spiritual, emotional, and physical pain.
With the unprecedented surge in innovative new biotech and pharma companies, you’re growing to meet this increasing demand. Will you tell us about your team and some of your expansion efforts?
Science and research continue to move at the light speed to meet the demands of a pandemic and chronic diseases where there are few or no options when patients fail to respond to traditional or current dosing regimens. JYA’s growing network of experienced veterans from inside and outside the FDA work closely with our clients to ensure that their medical products are both safe and effective with minimal side effects. Importantly, Gary Brennan and Monique Mendoza will assume the day-to-day operations, allowing me to take on more a strategic advisory board member role starting in 2023. As a role model, we believe that we can be not only consultants, but also “life coaches” to those working or aspiring to be the next generation of quality and operations leaders.
What single piece of advice would you share with other aspiring leaders?
Remember to do what’s right, even in the face of business pressures. The right decisions are not always the easy ones, but they do define your integrity and your legacy. Value the people that are closest to you and let them know that they are appreciated by dropping them a simple email or text to let them know you’re thinking about them. Walk humbly and learn from your mistakes!
Jeff, let’s end with where we began—your devotion to serving the greater good. As part of your lifelong mission, JYA is also very active in supporting organizations and causes. How are you giving back?
Long before JYA existed, God placed a burning passion and humble desire in me to make a difference and to give back to society and the world. There remains much for all of us to do as citizens of the world, whether that be working to ensure that spiritual, emotional, and physical healing is made accessible to those who are deprived or preserving the natural wonders of this planet. When my father passed, I reflected on my life and where I’m supposed to be going. For us, it’s about giving back, and I’m committed to doing my part.
Jeff holds a BS in biological sciences from UCI, An MPH from UCLA, and an MBA from National University.
Founder, President & CEO
Jeff Yuen & Associates, Inc.