Theo turns complex FDA and health care regulations into clear, actionable strategies that help clients innovate, grow and stay ahead of risk.
Overview
From Fortune 5 companies to fast-growing startups, Theo helps clients navigate FDA, HIPAA and False Claims Act requirements with confidence, translating complex legal challenges into practical solutions that advance business objectives.
He has partnered with pharmaceutical and medical device companies to design and maintain quality systems that meet FDA standards, balancing rigorous compliance with operational efficiency. Theo’s experience working for global medical companies gives him a unique perspective on the intersection of law and business, allowing him to provide solutions that are both legally sound and commercially viable.
With a collaborative, client-first approach, Theo is committed to helping organizations navigate the regulatory landscape confidently, to minimize risk and seize opportunities in an ever-evolving health care market.
Experience
Advised as an expert witness on FDA medical device reporting regulation and guidance in federal qui tam (False Claims Act) litigation.
Drafted quality agreements and counseled multi-national corporation with substantial manufacturing expertise but without in-house FDA experience.
Drafted internal procedures and negotiated manufacturing agreements for cosmetic manufacturer to comply with the Modernization of Cosmetic Regulation Act (MoCRA).
Counseled cosmetic manufacturer on product labeling requirements under FDA regulations.
Reviewed competitor’s website and submitted findings to FDA’s Office of Regulatory Affairs (ORA) citing non-compliance with FDA advertising laws and regulations.
Drafted clinical research agreements for medical device manufacturer conducting a multi-site study in the U.S. and Europe.
Drafted Business Associate Agreements (BAA) for laboratory service provider and various health care facilities.
Reviewed device manufacturer’s advertising and promotional material to ensure compliance with FDA and FCC laws and regulations.
Counseled clients on the application of the CAN-SPAM Act and Telephone Consumer Protection Act (TCPA) to their advertising practices.
Drafted and updated privacy policies for manufacturer’s websites to ensure compliance with changing data privacy laws.
Drafted quality agreement for clinical-stage biologics manufacturer with complex manufacturing processes across multiple international jurisdictions.
Created a pharmaceutical company’s Quality System to comply with FDA regulatory requirements, allowing the client to legally market their product.
Audited medical device company’s quality system to position client as a target for acquisition.
Counseled client on best practices for complaint handling and medical device reporting under 21 C.F.R. Parts 820 and 803, respectively.
Counseled client on safely marketing their product under Section 361 of the Public Health Services Act and in accordance with FDA guidance.
News & Insights
News
Speaking Engagements
"FDA Forum Panel," Minnesota State Bar Association CLE, April 2025
"Legal and Regulatory Issues Related to Weight Loss Drugs (GLP-1s)," Minnesota State Bar Association CLE, March 2025
"Trademark and Copyright Law: Your Questions Answered," October 2016
"The Hague Treaty on Industrial Designs," September 2015
Publications
Cybaris®: An Intellectual Property Law Review, Vol. 7, Issue 1
Professional & Civic Activities
Professional & Civic Activities
Minnesota State Bar Association (MSBA) Food, Drug, and Device Law (FDDL) Section
- Chair, 2025-2026
- Vice Chair, 2024-2025
- Vice Treasurer, 2023-2024
- Vice Secretary, 2022-2023
Practices & Industries
Admissions
- Minnesota
- U.S. Patent and Trademark Office
Education
Kyushu University, Faculty of Law, LL.M., 2013
William Mitchell College of Law, J.D., 2011
- Cybaris®, an Intellectual Property Law Review, Editor-in-Chief
- CALI Award Recipient for Patents I class
University of Iceland, Fulbright Scholar, 2008
College of Saint Scholastica, B.A., Biochemistry, History, 2003
