Ellen Pasquale represents companies and individuals with government-facing civil investigations, independent investigations, and civil litigation brought under various federal and state regulations. She has a particular focus on conducting internal investigations into regulatory breaches and misconduct, designing investigation plans, interviewing employees on-site, and managing document reviews. When government investigations or False Claims Act enforcement actions arise, Ellen coordinates document collection and analysis, prepares responses to Department of Justice and agency inquiries, and develops factual summaries to inform defense strategies.

Ellen Pasquale also assists life sciences clients in navigating enforcement and compliance under the federal Food, Drug, and Cosmetic Act (FDCA) and Current Good Manufacturing Practice (CGMP) regulations. Her work includes investigating product safety concerns, data integrity issues, and whistleblower claims to help clients mitigate risk and maintain regulatory standards. Ellen additionally supports food, drug, and cosmetic companies in achieving and sustaining compliance with the Food and Drug Administration’s CGMP requirements by drafting responses to Form 483 observations and warning letters.

Prior to joining Bass, Berry & Sims, Ellen was an associate at Sidley Austin LLP working with life sciences and healthcare clients. She earned a law degree from Vanderbilt Law School and an undergraduate degree in international studies from American University, School of International Service.