McGuireWoods provides sophisticated guidance to pharmaceutical companies on a wide range of operational compliance program issues, ensuring that they navigate complex regulatory landscapes effectively. Our team has deep experience advising on both pre- and post-market pharmaceutical compliance, including:


Compliance program creation, establishment of a RAMP, program gap assessmentsPreparing compliance policies, training, monitoring and auditing plansFederal/State Sunshine Reporting + State TransparencyConducting internal compliance investigations and advising on remediation plansSelf-disclosure protocolsBoard education and training on compliance program matters, DOJ and OIG guidanceFDA regulatory compliance, including IND, NDA and post-market obligationsRisk management strategies for advertising, promotion, sales initiatives, speaker programs, adverse event reportingMedicare and reimbursement compliance, including pricing and reimbursement issues

Our Life Sciences Team brings strategic consulting, compliance support, and litigation services for companies navigating FDA and CMS regulations, with a team composed of seasoned attorneys including former in-house counsel and government attorneys.