Her practice focuses on counseling clients on compliance in a wide range of relevant laws and regulations, such as the FD&C Act, FDA regulations, Anti-kickback Statute, False Claims Act, and relevant privacy and disclosure laws (HIPAA, Sunshine, etc.). Beth also works extensively in developing compliance policies and delivering training on these topics, as well as assisting clients with FDA marketing submissions and applications (pre-submissions, 510(k)s, de novos, PMAs, etc.), and drafting and negotiating contracts (consulting agreements, NDAs, CTAs, etc.).