A.J. Carvalho advises medical device, pharmaceutical, biotechnology, and laboratory companies on FDA regulatory and compliance matters across the full product lifecycle. He partners with clients…
A.J. Carvalho advises medical device, pharmaceutical, biotechnology, and laboratory companies on FDA regulatory and compliance matters across the full product lifecycle. He partners with clients to navigate complex product quality requirements, respond to enforcement risks, and resolve challenges that arise during product development and commercialization, with a focus on achieving practical, business-oriented outcomes.
A.J. brings investigations and white collar experience that allows him to counsel companies through government inquiries, internal reviews, and high-stakes compliance matters, especially in cross-practice contexts. He regularly advises on inspection readiness, FDA Form 483 responses, data integrity reviews, and other significant compliance events arising from agency inspections and enforcement activity both domestically and around the globe. A.J. frequently works closely with Covington’s investigations, litigation, and transactional teams to ensure regulatory strategies are integrated with clients’ other legal concerns and overarching business goals.
Prior to joining the Food, Drug, and Device Practice Group, A.J. was a member of the firm’s Patent Litigation and White Collar Defense and Investigations Practice Groups. He has represented innovative pharmaceutical and biotechnology companies in Hatch-Waxman patent litigation and advised life sciences clients in connection with civil and criminal investigations by the Department of Justice and FDA, helping clients manage risk and advance strategic objectives. He leverages this experience to inform his regulatory advising and better understand his client’s business goals.
Before entering private practice, A.J. served as a clinical research coordinator at Walter Reed National Military Medical Center, where he conducted exploratory research on blast injuries, advanced prosthetics, and related conditions. His work has been published in numerous peer-reviewed scientific journals.
A.J. maintains an active pro bono litigation practice alongside his client work. He was named a Young Lawyer of the Year by the Bar Association of the District of Columbia in recognition of his leadership in fundraising for DC Legal Aid’s 2025 Making Justice Real Campaign.
A.J. Carvalho advises medical device, pharmaceutical, biotechnology, and laboratory companies on FDA regulatory and compliance matters across the full product lifecycle. He partners with clients…
A.J. Carvalho advises medical device, pharmaceutical, biotechnology, and laboratory companies on FDA regulatory and compliance matters across the full product lifecycle. He partners with clients to navigate complex product quality requirements, respond to enforcement risks, and resolve challenges that arise during product development and commercialization, with a focus on achieving practical, business-oriented outcomes.
A.J. brings investigations and white collar experience that allows him to counsel companies through government inquiries, internal reviews, and high-stakes compliance matters, especially in cross-practice contexts. He regularly advises on inspection readiness, FDA Form 483 responses, data integrity reviews, and other significant compliance events arising from agency inspections and enforcement activity both domestically and around the globe. A.J. frequently works closely with Covington’s investigations, litigation, and transactional teams to ensure regulatory strategies are integrated with clients’ other legal concerns and overarching business goals.
Prior to joining the Food, Drug, and Device Practice Group, A.J. was a member of the firm’s Patent Litigation and White Collar Defense and Investigations Practice Groups. He has represented innovative pharmaceutical and biotechnology companies in Hatch-Waxman patent litigation and advised life sciences clients in connection with civil and criminal investigations by the Department of Justice and FDA, helping clients manage risk and advance strategic objectives. He leverages this experience to inform his regulatory advising and better understand his client’s business goals.
Before entering private practice, A.J. served as a clinical research coordinator at Walter Reed National Military Medical Center, where he conducted exploratory research on blast injuries, advanced prosthetics, and related conditions. His work has been published in numerous peer-reviewed scientific journals.
A.J. maintains an active pro bono litigation practice alongside his client work. He was named a Young Lawyer of the Year by the Bar Association of the District of Columbia in recognition of his leadership in fundraising for DC Legal Aid’s 2025 Making Justice Real Campaign.
