Cynthia Culmo

Cynthia Culmo has over 25 years of experience in the interpretation and implementation of Food and Drug Administration, global, and state regulatory requirements for medical devices, pharmaceuticals, biologics, combination products, medical foods, and medical marijuana as a non-lawyer.

Cynthia spent 12 years at the Texas Department of Health, as the Director of Drugs and Medical Devices, where she was a fully FDA commissioned official for all FDA regulated products, responsible for FDA inspections, compliance, and legal actions. As an industry senior management executive and consultant she has designed and implemented quality systems for regulated products and assisted in developing and implementing corrective actions to address regulatory gaps. Cynthia also advises on responses to agency enforcement actions, and works closely with clients to develop and implement remediation strategies and prepare for future inspections.