Perspective Pharmacovigilance is proud to share that we’ve expanded our expertise with professionals who bring direct leadership experience from the U.S. Food and Drug Administration (FDA). Their insight enhances how we support clients in aligning global pharmacovigilance practices with the expectations of regulators, investors, and patients.
For our clients, this means access to deeper regulatory perspective, earlier strategic planning, and guidance that reflects how safety and risk management are evaluated in practice. This expansion reinforces PPV’s mission to help small and emerging biopharma companies demonstrate safety value early and scale PV systems that stand up to inspection worldwide.
FDA Experience that Drives Innovation
Our new colleagues bring hands-on knowledge from their work advancing regulatory science and safety policy within the FDA. Their experience includes:
• Development of REMS frameworks, guidance, and public dashboards
• Cross-industry collaborations and publications advancing global risk management practices
• Development, modification, and evaluation of risk management strategies
• Regulatory leadership across multiple therapeutic areas
Their contributions have helped shape how our industry approaches patient safety, benefit-risk communication, and lifecycle risk management. This experience now helps PPV clients move from compliance-focused pharmacovigilance to strategic, data-driven safety programs that anticipate what regulators will expect next.
What This Means for Our Clients
Direct access to former FDA expertise brings practical value at every stage of product development. Our clients gain:
• Strengthened risk management strategies and REMS design support
• Greater insight into regulator expectations during submissions and inspections
• Earlier demonstration of safety value in development and review
This insight helps companies make confident, evidence-based decisions that accelerate readiness for both regulatory and market milestones.
Advancing PPV’s Mission
At Perspective Pharmacovigilance, our mission is to help small and emerging biopharma companies demonstrate safety value early, navigate regulatory complexity with confidence, and deliver scalable PV solutions that align with global standards. Expanding our team with former FDA leadership enhances that mission by combining regulatory depth with practical, implementation-focused expertise.
Our approach connects strategy with execution. By integrating regulatory foresight, scientific rigor, and operational efficiency, PPV helps clients achieve both compliance and competitive advantage through smarter pharmacovigilance.
Conclusion
The addition of former FDA leadership deepens PPV’s ability to deliver meaningful, forward-looking support to our clients. It provides direct insight into how regulators think, what drives policy evolution, and how to position safety systems for long-term success.
Perspective Pharmacovigilance remains committed to advancing patient safety and regulatory excellence for biotech innovators worldwide. To learn how this expanded expertise can support your development and compliance goals, contact our team to start the conversation.
