AZBioPEERS with Regulatory Expert Michelle Lott
Channel: AZ Bio
Date: 2021-11-28

Since 2010, Michelle Lott has been on a mission, helping more than 100 smaller companies with all things regulatory – strategy and planning, regulatory submissions, audit preparation and remediation, due diligence, quality systems, compliance and more. Topics that many companies view as unwelcome burdens and expenses to be borne as part of any healthcare, cosmetic or edible product’s go-to-market plan. But Michelle's clients know that putting regulatory and strategy together will give them a competitive advantage in the marketplace. It's not always easy, and dealing with regulators can be emotionally draining, but Michelle is a certified regulatory grief counselor, ready to guide clients through the five stages to acceptance and product launch success. Michelle graduated Magna Cum Laude from Troy State University in Alabama with a bachelor’s degree in chemistry. She served a term on the FDA’s Device Good Manufacturing Practices (CGMP) Advisory Committee, providing strategy and guidance to the FDA on key healthcare industry topics, and in 2013 completed Northwestern University’s Kellogg School of Management Regulatory Affairs Professionals Society (RAPS) Executive Development Program. She has served as a regulatory participant in the Global Enteral Device Supplier Association (GEDSA) and has been a member of The International Consortium on Systems Engineering (INCOSE), serving as sub-team lead for their Model Based System Engineering Healthcare Working Group. But Michelle is not all work and no play. She and her husband share a house with three dogs – the LeanRAQA Dream Team featured prominently in her social media posts. She has a Southerner’s deep-rooted weakness for anything barbecued and a taste for tequila nurtured during her time in Arizona and Mexico. When asked at parties, Michelle’s fun fact is that she served as an expert witness in forensic toxicology for the Mississippi State Crime Lab.