Marissa Chaet Brykman, Esq.
Quality & Compliance Practice
BACKGROUND
FOCUS AREAS
Senior regulatory advisor for life sciences companies on FDA compliance, product quality, regulatory policy, and advertising and promotion, leveraging experience across government and industry sectors.
Regulatory Compliance and Enforcement
Regulatory Policy
Manufacturing and Compounding
Advertising and Promotion
Marissa is a Senior Vice President in the Quality and Compliance Practice, where she provides strategic guidance to life science companies on a broad range of regulatory compliance and policy matters, including product quality, manufacturing, compounding, and advertising and promotion.
Marissa brings over a decade of experience from the U.S. Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research (CDER). Specifically, in the Office of Compliance, Office of Manufacturing Quality, Marissa served as a Regulatory Counsel and advised on regulatory and enforcement actions related to drug manufacturing and compounding compliance. She also worked in the Office of Unapproved Drugs and Labeling Compliance, within the Compounding and Pharmacy Practices Branch, where she supported the development of compounding guidances and regulations implementing the Drug Quality and Security Act. Marissa was also a Regulatory Counsel in the Office of Prescription Drug Promotion, where she provided counsel on regulatory reviews and compliance actions related to prescription drug advertising and promotion.
Following her tenure at FDA, Marissa was the Director of U.S. Regulatory Policy at a non-profit standards organization, where she focused on regulatory policy initiatives related to product quality. She was also an Assistant General Counsel at a pharmaceutical company, where she advised on product quality, manufacturing compliance, advertising and promotion, regulatory affairs, and medical affairs matters. Earlier in her career, Marissa was a patent examiner at the U.S. Patent and Trademark Office.
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EDUCATION:
Juris Doctor, Catholic University of America, Columbus School of Law
Bachelors of Arts in Chemistry, Duke UniversityCERTIFICATIONS:
Certificate, American Course on Drug Development and Regulatory Sciences (ACDRS), University of California, San Francisco
Certificate, FDA Basic Drug SchoolASSOCIATIONS:
State of Illinois Bar, November 2006
Patent Bar, June 2008
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