HP&M is Pleased to Welcome Lisa Baumhardt (Senior Medical Device Regulation Expert) and Sophia Gaulkin (Associate) to the Firm

Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Lisa M. Baumhardt, MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate.

Ms. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.  In the pre-market area, Ms. Baumhardt develops regulatory strategies, prepares pre-submissions and regulatory market authorization submissions, drafts regulatory policies and procedures, and reviews advertising and promotional materials.  In the post-market area, Ms. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters.

Prior to joining the Firm, Ms. Baumhardt was the Regulatory Affairs/Quality Assurance Executive for medical devices at IBM, where she worked on new and novel artificial intelligence/machine learning technologies.  She has also held positions in regulatory affairs, clinical affairs, quality assurance, and compliance at Mallinckrodt Pharmaceuticals, GE Healthcare, and Abbott Laboratories.

Ms. Baumhardt earned a Master’s in Jurisprudence from Loyola University Chicago School of Law, a Master’s in Healthcare Technology Management from the Medical College of Wisconsin and Marquette University and a Bachelor of Science in Medical Technology.

Ms. Gaulkin assists clients across a range of pre- and post-marketing regulatory matters relating to dietary supplements, food products, drugs, medical devices, cosmetics, pet products, and consumer products.  She advises clients on compliance issues, including packaging, labeling and claim substantiation, state licensure requirements, e-commerce platforms, and drug pricing reporting.  She also assists with transactional due diligence, internal investigations, and supplier subcontracts and negotiations.  In addition, Ms. Gaulkin has published on a range of emerging issues related to food and drug regulation, from color additives and flavors in oral drug products to master protocols in the era of COVID-19, FTC- and USDA-regulated labeling claims, and the edible insect industry.

Before joining HP&M, Ms. Gaulkin practiced FDA law at an AmLaw 100 firm. She earned her J.D. from the University of Pennsylvania Law School and her B.A., magna cum laude, from Hamilton College.