Maxine K. Fritz has over 25 years of experience in government and private-sector regulatory management. She specializes in providing strategic scientific and regulatory consulting services to healthcare clients and their counsel, focusing on managing complex challenges in regulatory compliance, public policy, and litigation. Her expertise spans Quality System Implementation, Training, Validation, Expert Witness/Litigation Support, and regulatory strategy development. 

A former FDA investigator who specialized in biological and pharmaceutical product inspections and served as the Biologics Team Leader. During her FDA tenure, she was responsible for two Consent Decrees, multiple Warning Letters, several new product approvals, and three prosecutions. Ms. Fritz received several FDA Awards including Investigator of the Year – Los Angeles District, 1997 and 1998, FDA Outstanding Achievement Award, 1998, Biologics Team National Award, 1996, Recognition Award for assistance provided during the SCPDG/OCRA, Grassroots Imports, and Biotechnology Conferences, Recognition Award for the performance of high priority plasma sampling of an HIV contaminated pool; first samples collected in US, Recognition Award for the training of Los Angeles laboratory personnel in inspectional basics, Recognition Award for precedent-setting BIMO criminal case and Crisis Team Management Award for role as a lead investigator during a National New Year’s Eve crisis, involving misbranded drugs. 

With extensive experience in senior management, quality assurance, data integrity, product release, investigations, cGMP training, and aseptic manufacturing, Ms. Fritz combines deep technical knowledge with practical regulatory strategies. She has successfully guided clients through complex compliance projects involving corporate Warning Letters, Mass Seizures, Consent Decrees, AIPs, Prosecutions, and Import Detentions, helping them achieve regulatory alignment and operational excellence on a global scale.