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Carol Gloff & Associates is a specialized consultancy founded in 1996 by Dr. Carol A. Gloff, providing expert advice to medical product companies and academic institutions in areas such as product development, regulatory affairs, quality assurance, compliance, pharmacokinetics, nonclinical pharmacology/toxicology programs, early-stage clinical studies (for both drugs and biologics), chemistry/manufacturing/control activities (CMC), and regulatory strategy. The firm leverages Dr. Gloff’s extensive experience across the pharmaceutical industry.
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