Alexis Northcutt | Quantum Regulatory Solutions

Alexis Northcutt, PhD, RAC

PRINCIPAL REGULATORY STRATEGIST

Alexis is an experienced regulatory professional and neuroscientist who joined Quantum in May 2023 as a Regulatory Strategist. She brings over 7 years of drug and device regulatory affairs experience with a strong technical background in neuroscience and microbiology. With a focus on premarket strategy and development, Alexis has expertise in supporting and leading FDA interactions and submissions, including FDA meetings, marketing applications, and INDs/IDEs. Alexis provides support to a wide-range of partners from small start-ups to well established biotech programs, meeting client specific needs by providing strategic input and oversight, regulatory writing, and serving as a regulatory lead in cross-functional settings. Alexis is skilled at building collaborative, strong relationships with client partners and regulatory authorities and is passionate about supporting the development of safe, effective, and innovative treatments for a range of indications.