Dr. Tom Colonna, PhD JD
Senior FDA regulatory and clinical strategist with 30+ years of experience guiding medical devices, biologics, pharmaceuticals, software, and food products through high-stakes FDA regulatory decision points.
Dr. Tom Colonna brings deep expertise in FDA regulatory strategy, scientific evaluation, and legal analysis across medical devices, biologics, pharmaceuticals, dietary supplements, food products, and biomedical software. With dual training in molecular biology and law, he has advised executive teams, law firms, and global manufacturers on regulatory pathway strategy, submission development, enforcement risk, and Agency engagement; particularly in complex or precedent-setting matters where scientific and legal considerations must be tightly aligned.
Areas of Focus / Expertise
- FDA regulatory pathway and classification strategy across devices, biologics, drugs, food, and supplements
- Premarket submissions (IDEs, 510(k)s, PMAs, NDAs/BLA support)
- Biomedical software and digital health regulation
- cGMP and cGCP compliance strategy and training
- Regulatory documentation, labeling, and promotional review
- FDA meeting preparation and strategic communications
- Regulatory risk assessment and enforcement response
- Academic program development in regulatory science and food safety
Selected Experience & Impact
Over the course of his career, Dr. Colonna has prepared regulatory submissions, opinion letters, and compliance strategies for multinational companies, emerging biotechnology firms, and leading law firms. As Founder of Biotech Consultant LLC, he has supported medical device, biologics, pharmaceutical, and food-sector clients in navigating complex FDA requirements. He also founded and directed graduate programs in Regulatory Science and Food Safety Regulation at Johns Hopkins University, serving as Co-Investigator on the FDA-funded Center of Excellence in Regulatory Science and Innovation (U01 FD004977).
Background & Credentials
Prior to FDA Partners, Dr. Colonna served in the FDA Medical Device and Biologics Regulation Group at Hogan & Hartson LLP, advising on IDEs, 510(k)s, PMAs, and related regulatory matters. He later founded Biotech Consultant LLC and held academic leadership roles at Johns Hopkins University, where he created and directed master’s programs in Regulatory Science and Food Safety Regulation. He holds a JD from Georgetown University Law Center, a PhD in Molecular Biology from Johns Hopkins University, and a BS in Microbiology.
Dr. Colonna integrates scientific depth, legal precision, and regulatory strategy to help organizations navigate FDA complexity with disciplined execution and practical risk management.