A highly experienced pharmaceutical expert with over four decades of experience in research and development, quality operations, and regulatory affairs. For nearly three decades, this consultant has provided advisory services to clients, including regulatory application strategies, current Good Manufacturing Practice (cGMP) quality system regulation audits, and due diligence assessments. This expert has contributed to numerous regulatory approvals for various drug and drug/device applications, ranging from generic to innovator products. Experience includes resolving regulatory compliance issues such as data integrity, Form 483s, Warning Letters, and Consent Decrees. Additionally, this expert has held interim and contracted senior management roles in regulatory and quality for pharmaceutical companies of all sizes, and served as a US Agent for international firms. This expert has also served as a subject matter expert witness in >20 legal proceedings.
✓ Depositions
✓ Trial Testimony