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About
Franklin Mathews Group is a BioPharma quality and regulatory intelligence consulting company, consulting for companies regulated by the United States Food & Drug Administration (FDA).
Our Expertise
Our founder, Marie Mathews, is an 18 year+ veteran of FDA: former distinguished investigator and served as both a field and a CDER OC compliance officer. She is an experienced compliance professional with skills in identifying organizational regulatory, quality, and reputational risks and devising solutions that focus on patient needs. She has expertise in pharmaceutical, biologics and medical device industry quality with an emphasis on sterile processing.
Our Commitment to Results
In addition to our own consultants, we maintain a subject matter expert network to provide you with the best advice for even your most complex techinical challenges. We will make sure we find you the best answers to even the most difficult questions.
Our Philosophy
We believe in the principles of W. Edwards Deming, including:
"Inspection with the aim of finding the bad ones and throwing them out is too late, ineffective, and costly. Quality comes not from inspection but from improvement of the process."
We identify and mitigate risks in your processes.
Our Experience
As mentioned, Marie Mathews has extensive FDA experience and was the former Associate Director of GxP External Engagement for Bristol Myers Squib. She has over 30 years of academic, regulatorory and business experience in the BioPharma sector. She is also a highly rated speaker at major GxP conferences on FDA policy, regulatory intelligence, compliance, and mature quality cultures.
Marie Mathews
Founder & Principal
Marie spent most of her career with the US FDA, where she most recently served as a compliance officer with the FDA CDER Office of Compliance/Office of Manufacturing. She spent nine years as an investigator covering medical device manufacturers, clinical trials, and drug manufacturing and served on the foreign inspection cadre. She received the FDA Individual Commendable Service award for her work as the lead investigator on a sterile medical device prosecution case. She also worked as a field compliance officer specializing in drugs, veterinary drugs and biologics where she handled several injunction cases, some of which included monitoring long term multi-million-dollar remediation plans. She received her B.S. and Master of Science in Pharmacy/Regulatory Affairs from the University of Georgia. She is a highly rated speaker at major GxP conferences on FDA policy, compliance risks, and mature quality cultures.
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