- Helped guide a medical device startup with the importation and distribution of FDA-authorized COVID-19 antigen tests under COVID-19-modified state licensing requirements to fulfill critical needs.
- Assisted the new equity owner of a national specialty pharmacy network with the transfer of more than 100 state licenses following a change of ownership.
- Helped a prescription medical device manufacturer and distributor navigate state requirements in states with jurisdiction over medical devices vs. states that do not regulate or license medical device establishments.
- Assisted a product delivery company by analyzing state regulatory requirements for the delivery of cannabis-derived products and recommending an operational strategy that minimized enforcement risks.
- Analyzed 483 responses for a pharmaceutical manufacturer.
- Identified labeling and enforcement materials relevant to an internal analysis of a pharmaceutical manufacturer’s policies regarding medication use claims.
- Helped a leading restaurant chain identify the regulatory risks of selling or donating COVID-19 tests to franchisees.
- Drafted a legal opinion emphasizing the inapplicability of a state’s medical device distribution regulations, which enabled the client to continue its activities in the state in question.
- Phone: +1 202 239 3163
- Email: firstname.lastname@example.org
Anthony, a licensed pharmacist, relies on his pharmacy background and experience as a pharmaceutical licensing consultant to guide FDA-regulated clients through regulatory and enforcement actions.