Kalie E. Richardson

Kalie E. Richardson focuses her practice on post-marketing regulatory compliance and enforcement, primarily for pharmaceutical manufacturers.  She has recently attended several unannounced FDA surveillance inspections of drug and device manufacturers, and prepared responses to Form FDA 483 Inspectional Observations, Warning Letters, and Untitled Letters issued to manufacturers, outsourcing facilities, and wholesale drug distributors.  Ms. Richardson regularly helps clients navigate post-inspection corrective actions and has a particular interest in data integrity remediation and internal compliance investigations.

Ms. Richardson also provides guidance to manufacturers, wholesale distributors, 3PLs, and pharmacies on state licensing strategy and compliance.  She has recently represented clients in disciplinary proceedings before state regulators in Alabama, Arizona, Kentucky, Maryland, Montana, New Hampshire, and South Carolina.  Ms. Richardson also counsels stakeholders throughout the supply chain on compliance with the requirements of the Controlled Substances Act (CSA) and Drug Supply Chain Security Act (DSCSA).

Ms. Richardson is a French translator by education, with a focus on medical and pharmaceutical texts.  Before attending law school, Ms. Richardson worked for a patient support program in Toronto, Canada.  Prior to joining the firm, Ms. Richardson practiced food and drug law at another law firm in both DC and Atlanta.  Ms. Richardson received her juris doctor degree from Emory University School of Law.  During law school, Ms. Richardson worked in the Centers for Disease Control and Prevention, and the Office of Regulatory Policy at the Center for Drug Evaluation and Research of the Food and Drug Administration.