Marie F. Mathews

Marie F. Mathews

Senior Consultant

Ms. Mathews has over 18 years of Food and Drug Administration experience, including nine years as an award-winning FDA investigator, conducting investigations and inspections of a wide variety of regulated products, which covered the manufacturing of drugs, dietary supplements, medicated feeds, biologics, and medical devices. She enjoyed auditing products made via complex processes, like terminal sterilization or aseptic filling operations. She also performed FDA inspections of good clinical practices involving drugs and medical device clinical trials. Ms. Mathews has performed many FDA criminal investigations, including one that resulted in the successful prosecution of a sterile medical device manufacturer.

She spent another nine years as both a field compliance officer and at the FDA Center for Drug Evaluation and Research, working closely with the FDA’s decision makers and subject matter experts in drafting and issuing warning letters for violations of current Good Manufacturing Practices.

She also worked for Emory University’s Institutional Review Board, CDC’s Strategic National Stockpile, and most recently as a regulatory intelligence associate director for Bristol Myers Squibb, a global biopharmaceutical company.

She has been a highly rated speaker at major Good Manufacturing Practices conferences, presenting on FDA policy, compliance, and mature quality cultures.

She received both her Bachelor of Science in Zoology and Master of Science in Pharmacy, Regulatory Sciences from the University of Georgia.

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430 Technology Parkway NW Peachtree Corners, GA 30092
  • Phone: (678) 990-3280
  • Fax: (678) 990-3285

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ESi's expertise spans dozens of industries and specializations organized across several practice groups, each staffed by dozens of in-house experts with the technical knowledge, hands-on expertise, and courtroom experience required to execute projects for and with our clients from start to finish.

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