Based on a conversation between Philip Crowley, Esq. from Crowley Law LLC and Troy Fugate, Co-founder of Compliance Insight, on a recent episode of the “From Lab to Patient, Garage to Market Podcast“
The phrase “trust but verify” might have originated during Cold War diplomacy, but it perfectly encapsulates the foundation of successful relationships with regulatory authorities today. Troy Fugate, Vice President and Co-founder of Compliance Insight, has observed a consistent pattern over his two decades of working with life science companies: those who understand this principle thrive, while those who miss it struggle unnecessarily.
The Human Element in a Technical World
Many life science entrepreneurs approach regulatory compliance as a purely technical challenge. They meticulously prepare their data, polish their documentation, and perfect their processes. While these elements are crucial, they’re only half the equation. Fugate emphasizes that regulatory relationships, like all professional relationships, have a fundamentally human component.
Regulators aren’t just reviewing documents; they’re engaging with teams, assessing commitment to quality, and evaluating transparency and reliability. As Troy often reminds his clients, regulators are people who, just like everyone else, put their shoes on one foot at a time and have good days and bad days.
Building the Foundation: Early Engagement
According to Fugate’s experience with hundreds of life science companies, the question isn’t whether to engage with regulatory authorities, but when. The answer, perhaps surprisingly to some, is earlier than most companies think. Here’s why:
- Early dialogue shapes understanding
When companies engage early, they have the opportunity to help regulators understand their technology, approach, and thinking. This understanding becomes invaluable as products progress through development. - Relationship building takes time
Trust isn’t built overnight. Each interaction, each demonstration of transparency and competence, adds another brick to the foundation of trust being built. - Course corrections are easier early
Small adjustments in early development are far less costly and disruptive than major changes later in the process.
The Verification Mindset
Understanding that verification is part of the process—and not taking it personally—is crucial. Fugate emphasizes that when regulators verify work, they’re doing their job: protecting public health and safety. This isn’t a sign of distrust; it’s their mandate.
He offers this perspective: If a company is doing quality work and maintaining proper documentation, verification becomes an opportunity to demonstrate competence rather than a challenge to defend against.
Practical Steps for Building Trust
Through years of guiding companies through regulatory processes, Troy has identified key elements for building trust:
- Transparent Communication
- Be proactive in sharing both successes and challenges
- Maintain open dialogue about potential issues
- Document decision-making processes clearly
- Consistent Reliability
- Meet commitments and deadlines
- Maintain quality in all submissions
- Follow through on promised actions
- Professional Empathy
- Understand the regulator’s perspective and mandate
- Recognize the pressures and constraints they operate under
- Appreciate their role in public health protection
Common Pitfalls to Avoid
From Fugate’s extensive experience, these are the most problematic approaches:
- The Adversarial Approach
Viewing regulators as obstacles rather than partners creates unnecessary tension and can lead to defensive behaviors that undermine trust. - Information Filtering
Selectively sharing information or attempting to “manage” the message too tightly can backfire. Regulators appreciate honest, straightforward communication. - Reactive Engagement
Waiting for problems to arise before engaging with regulatory authorities misses valuable opportunities for relationship building.
The Long-Term View
Building strong regulatory relationships is a marathon, not a sprint. The investment companies make in these relationships early will pay dividends throughout their product’s lifecycle. Compliance experts have observed these long-term benefits:
- More productive meetings and interactions
- Faster resolution of issues when they arise
- Greater flexibility in addressing challenges
- More efficient regulatory processes
Measuring Success
Fugate suggests looking for these indicators to evaluate regulatory relationship effectiveness:
- Quality of Interactions
- Open, productive discussions
- Constructive feedback loops
- Professional respect in communications
- Process Efficiency
- Smoother reviews
- More predictable outcomes
- Fewer surprises
- Mutual Understanding
- Clear expectations on both sides
- Shared understanding of goals
- Aligned approaches to challenges
Moving Forward
The key to building effective regulatory relationships lies in balancing technical excellence with human connection. Successful companies remember to:
- Start early
- Be transparent
- Maintain consistency
- Think long-term
- Value the human element
The regulatory landscape in life sciences continues to evolve, but the fundamental importance of trust and verification remains constant. As Troy Fugate has demonstrated throughout his career, by investing in these relationships early and maintaining them thoughtfully, companies create a foundation for success that extends far beyond any single product or submission.
Compliance Insight Website: https://www.compliance-insight.com
Crowley Law LLC: https://www.CrowleyLawLLC.com