Supporting legal review of IND, NDA, BLA, and 510(k) submissions and advising on interactions with FDA during the approval process.
Drafting and negotiating agreements with CROs, clinical sites, investigators, and IRBs governing the conduct of human clinical studies.
Building and defending patent portfolios covering drug compounds, formulations, manufacturing processes, and diagnostic methods.
Structuring in-licensing, out-licensing, and co-development deals that define milestone payments, royalties, and commercialization rights.
Advising on interactions with healthcare professionals under the Anti-Kickback Statute, Stark Law, and PhRMA/AdvaMed codes.
Managing legal obligations under Medicaid best price, 340B, and government price reporting requirements.