Expert Profile |
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This drug development expert is a consultant to the pharmaceutical industry in quality assurance, regulatory affairs, and new product development. He is experienced in the Food and Drug Administration (FDA) regulatory requirements of drug development and approval, having filed investigational new drug (IND) applications, worked on clinical trials, and filed new drug applications (NDA). He has conducted good manufacturing practice (GMP) compliance audits and reviews. He managed the regulatory and marketing support of new drug development for a pharmaceutical company for over ten years. This expert has an MBA, a Ph.D. in Bacteriology, and has testified in deposition and at trial.
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Expert Witness Experience
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He has testified in deposition and at trial.
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Industry Experience
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- Pharmaceutical industry consultant in quality assurance, regulatory affairs, and new product development
- Experienced in the FDA regulatory requirements of drug development and approval
- Filed IND applications, worked on clinical trials, and filed NDAs
- Conducted GMP compliance audits and reviews
- Managed the regulatory and marketing support of new drug development for a pharmaceutical company
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Educational Background
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- Ph.D., Bacteriology
- MBA
- MS, Bacteriology
- BS, Biological Chemistry
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