Carol Pratt Esq.

Lee & Hayes PLLC
Pratt, Carol A.

Carol Pratt is a Partner in Lee & Hayes' Portland Metro office where her practice focuses on regulatory issues associated with research, development and FDA requirements that apply to bio-medical and health products, and serves as a member of the advisory boards of Law's Life Sciences Law & Industry Report and Medical Research Law & Policy Report. Dr. Pratt holds a Ph.D. in neuroscience and has an extensive background in medical research.

She provides practical, strategic advice to early stage and established life sciences clients on regulatory issues across the product lifecycle, from pre-clinical and clinical research, FDA pre-market requirements, labeling, and promotion and advertising, to post-market surveillance and enforcement.

Dr. Pratt advises industry clients on a diverse spectrum of medical and health products, including medical devices, drugs, biologics, dietary supplements and cosmetics. She has substantial experience with in vitro diagnostics, stem cells, nanotechnology, medical software, medical foods and exercise/sports supplements and beverages.

Dr. Pratt advises clients engaged in all aspects of pre-clinical and clinical research, including industry sponsors, academic medical centers, research hospitals, non-profit research organizations, Institutional Review Boards (IRBs), and Contract Research Organizations. She advises clients on compliance with FDA, DHHS and HIPAA regulations governing use of human subjects. She also advises clients on INDs and IDEs, genetic and stem cell research, financial conflicts of interest, research misconduct, creation, use and ownership of research databases and tissue repositories, federal anti-kickback and False Claims Act issues associated with budgets and reimbursement in clinical trials, and protection of IP in research collaborations. Dr. Pratt also assists clients in drafting and negotiating research agreements in industry sponsored or federally funded research.

Dr. Pratt received her B.S. from Bridgewater State College, her M.S. from the University of Massachusetts, her Ph.D. from the University of Manitoba, and her J.D. from the University of Oregon School of Law.