Maxine K. Fritz

Maxine K. Fritz brings over 25 years of experience in government and private-sector regulatory management. She specializes in strategic scientific and regulatory consulting for healthcare clients and their legal counsel, with expertise in quality system implementation, training and validation, expert witness and litigation support, and regulatory strategy development.

As a former FDA investigator, Maxine specialized in biological and pharmaceutical product inspections and served as Biologics Team Leader. She managed two Consent Decrees and multiple Warning Letters, oversaw several new product approvals and three prosecutions. Her FDA career included numerous recognitions, including Investigator of the Year for the Los Angeles District in 1997 and 1998, along with Outstanding Achievement Awards, national Biologics Team recognition, and crisis management commendations.

She brings extensive senior management experience in quality assurance, data integrity, product release, investigations, cGMP training, and aseptic manufacturing. Maxine has guided clients through complex compliance matters including Warning Letters, seizures, consent decrees, and import detentions, helping organizations achieve regulatory alignment globally.