Regulatory and Compliance

Jones Walker helps life sciences companies assess regulatory pathways, structure compliant development and commercialization strategies, and prepare for agency engagement and federal and state regulatory obligations involving FDA regulatory standards throughout the product life cycle. Our attorneys advise on clinical trial compliance, Good Clinical Practice (GCP) standards, institutional review board requirements, human-subject protections, product approvals, post-market responsibilities, and commercialization. We also assist with investigational new drug (IND) applications, new drug applications (NDAs), 505(b)(2) pathways, accelerated approval programs, and evolving regulations impacting digital health and AI. We also help clients align regulatory, exclusivity, life cycle management, and commercialization strategies to protect product value and market opportunity.