President
CurrentProvide regulatory compliance consulting services to the FDA.Project Leader for assessment and remediation of Quality Management and Quality Assurance Systems and Post-Market Safety Surveillance systems. Expertise in design of Quality Management Systems for clinical and commercial products for the global market. Expertise in development and implementation of company Quality Program strategies for partially or fully outsourced operations.Interim Monitor for the Federal Trade Commission for Pharmaceutical / Life Science Product Divestitures. Review Respondent and Acquirer activities in view of obligations in FTC Orders and divestiture agreements.. Lead activities of technical and regulatory resources to evaluate compliance. Facilitate discussion and resolution of issues between parties and at the direction of the Commission. Manage and conduct due diligence activities for acquisition or licensing of pharmaceutical and biotechnology products. Manage personnel and provide advice in support of contract with HHS/ASPR/BARDA to provide Subject Matter Experts for Medical Countermeasure development.Bar Admissions: Delaware, 2000 United States District Court for District of Delaware, 2001Regulatory Affairs Certified (1992)