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Suzanne Sensabaugh is the President and Principal Consultant of HartmannWillner, a FDA regulatory affairs and cGMP consultant specializing in biologics, biosimilars, biotechnology, and biologic device combination products. With over 30 years of experience in regulatory affairs, drug development, and FDA compliance, she has played a key role in the development of over 130 products. Suzanne has conducted over 30 FDA GMP audits and provided expertise to product development advisory boards, investment management, venture capital firms, and global management consulting firms. She has also served as an expert witness on FDA regulatory affairs and GMP compliance matters.
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Suzanne M. Sensabaugh is President and Principal Consultant of HartmannWillner, where she is a FDA regulatory affairs and cGMP consultant specializing in biologics, biosimilars, biotechnology, and biologic device combination products. She has over 30 years of experience in regulatory affairs, drug development, and FDA compliance. Her experience was gained in the FDA (ex-FDA), pharmaceutical industry, and as a regulatory affairs consultant. Since forming HartmannWillner in 2009, Suzanne has assisted in the development of over 130 products as a regulatory affairs consultant. During this same time period, she has conducted over 30 FDA GMP audits, to include preapproval inspections (PAI), and provided GMP compliance consulting. In addition, she has provided FDA regulatory consultant expertise to product development advisory boards, investment management and venture capital firms, and global management consulting firms. She has served as an expert witness on FDA regulatory affairs and GMP compliance matters and as a subject matter expert for NIH and OS/ASPR/BARDA Special Emphasis Panels for contract and proposal reviews for drug development funding. Also, Suzanne has served as an independent third party auditor (GMP outside consultant) to assist in meeting CGMP requirements.
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