Lowell M. Zeta

He counsels extensively on product quality, safety, and compliance with current good manufacturing practice (GMP) requirements and data integrity standards for clinical and commercial stage products, with a focus on next generation products with complex manufacturing and global supply chain considerations. He helps to resolve complicated quality issues, including by advocating for clients before FDA in regulatory meetings, inspection and enforcement action, and government investigations. 

He has deep experience supporting complex contract manufacturing arrangements, including manufacturing services agreements, quality agreements, and safety data exchange agreements. He excels by leveraging his awareness of the pressures facing life science companies, his on-site experience providing clients with real-time support at manufacturing facilities around the world, and his perspective on intra-agency decision-making processes.

He is at the forefront of the industry's digital transformation initiatives, helping to propel drug development programs by navigating evolving regulatory frameworks for digital health technologies, real-world evidence (RWE), novel biomarkers, and patient focused drug development. 

While at the FDA, he served as Senior Counselor to the FDA Commissioner providing leadership on cross-cutting and high-priority strategic initiatives, including the FDA COVID-19 PREPP initiative. He is a published author in peer-reviewed journals, and a public speaker on life science related topics.