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
