Theodore Sullivan

Experienced counsel on FDA regulations and matters

Theodore Sullivan counsels and advises clients on Food and Drug Administration (FDA) regulations and matters related to:

• Prescription and over-the-counter pharmaceuticals
• Medical devices
• Biological products
• Cosmetics
• Foods and dietary supplements

Theodore's medical and FDA-related work goes beyond his time at Quarles. He was legal counsel for an international medical device company, where he worked to launch the company’s subsidiary in the U.S., obtained pre-market approval for injectable medical devices and advised the company on FDA-related advertising, labeling, import/export, clinical and manufacturing issues. Before practicing law, Theodore was an FDA biologist at FDA’s National Center for Food Safety and Technology, where he conducted research into methods for detection of food-borne pathogens and toxins.

• Works extensively with medical device companies, including experience with premarket approval and premarket notification (510(k)) submissions. His device experience includes work with traditional medical devices as well as software devices and in-vitro diagnostic tests.
• Advises pharmaceutical clients on bringing their products to market and developing product life-cycle extension strategies. Clients reach out to Theodore for both pre- and post-approval matters on both human and veterinary drug products.
• Counsels clients with compliance matters, including manufacturing and clinical site inspections, import detentions and warning letter responses. He has extensive knowledge of the citizen petition and notice of opportunity for hearing processes.