About This Episode
In this episode of From Lab to Patient, Garage to Market, Phil Crowley sits down with Troy Fugate, founder of Compliance Insight and a regulatory affairs veteran with over 30 years of experience in the life sciences industry. Troy has worked across biotech, medical devices, and pharmaceuticals — and he’s seen firsthand what separates the startups that make it through the regulatory process from the ones that don’t.
What we cover:
- Why compliance has to be built in from day one — not bolted on later
- What early-stage life sciences companies consistently get wrong about FDA compliance
- How to build a quality culture that regulators actually trust
- CDMO partnerships — what to look for, what to avoid, and why this relationship can make or break your product
- The difference between phase-appropriate GMP and cutting corners
- Where AI fits into the future of regulatory strategy
About From Lab to Patient, Garage to Market
Your host, Philip P. Crowley Esq. is the founder and Managing Partner at Crowley Law LLC, a boutique corporate law firm focused on helping emerging tech and life sciences startups launch and reach their full potential. In each episode of From Lab to Patient, Garage to Market, Philip invites professionals serving the tech startup market to discuss various issues of importance in the industry and their part in it. Watch or listen to more episodes of From Lab to Patient, Garage to Market:
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