Whether clients need assistance in arranging a clinical trial to bring new, life-saving products to market, or operating a compliant advertising campaign for their existing product portfolio, Theo’s broad perspective helps answer questions efficiently and completely. He enjoys helping clients be successful so that they may focus on helping patients.
Theo’s practical experience gained from working on product development teams and representing companies before FDA in meetings and correspondence helps him to bridge the gap between FDA’s expectations and industry’s understanding of their legal and regulatory duties. He has been working with FDA-regulated companies for over a decade, advising them on issues concerning data privacy and cybersecurity practices, medical device reporting, as well as 510(k), Pre-Market Approval (PMA), and Investigational Device Exemption (IDE) submissions.
- Advise clients on privacy matters specific to FDA regulated companies.
- Counsel clients on product recalls of medical devices to ensure compliance with FDA requirements and best-practices.
- Negotiate quality agreements between manufacturers, medical device, and pharmaceutical companies.
- Advise clients on clinical trial agreements (CTAs) for conducting clinical trials for devices and drugs.
- Advised a pharmaceutical client on creating a quality system for pharmaceutical manufacturing so the client could legally market their product in the United States.
- Participated in a Federal trial as an expert witness on FDA medical device reporting (MDR) practices in a False Claims Act (FCA) litigation.
- Juris Doctor, William Mitchell College of Law
- Master of Laws, Kyushu University
- Bachelor of Arts, Biochemistry and History (double major), The College of Saint Scholastica
Bar Admissions and Qualifications
- United States Patent and Trademark Office
- Regulatory Affairs Certification (RAC)
- Certified Medical Device Auditor (CMDA)
- HealthCare Information Security and Privacy Practitioner (HCISPP)
- Council Member, Minnesota State Bar Association - Food, Drug and Device Law Section
Honors and Awards
- United States Department of State, Fulbright Scholar