Suzanne Sensabaugh is an 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 where she assisted in the development of more than 130 products. During this same time, she 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. Suzanne has also served as an independent third-party auditor (GMP outside consultant) to assist in meeting CGMP requirements.
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