Our managing director has been called upon to apply his diverse experience in designing, fixing, and being personally accountable for compliance and quality systems by providing Litigation Support in the fields of product liability, fraud, and records discovery associated with FDA compliance requirements. These consulting services have been sought after by investors, attorneys, and defendants.
Sobering as the subject is, studying compliance failures – plant shutdowns, quality system inspection reports, warning letters, recalls, insufficient supplier oversight programs, and/or records management disasters – helps us provide better analysis and insights through extensive awareness of the consequences of poor management, execution, or planning. There is probably no better education than to learn from the mistakes or consequences within one’s own profession.
Note: Given our continuing consulting work and speaking engagements in the industry, we prefer to serve as a “behind-the-scenes” expert. References provided upon execution of a mutual confidentiality agreement.