By Lisa Smith, Eric Kraus and Michelle Bonn  |  Law360  |  December 21, 2021, 6:44 PM EST

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Phillips Lytle special counsel George Hajduczok, Compliance Team RA/QA Consulting vice president Regina Fullin and Harvard Law School student Merve Ciplak contributed to this article.

About Compliance Team:
Since 2003, we have protected over 200 life science companies by assuring their quality systems, engineering validation programs and clinical studies consistently meet compliance standards. Our knowledge of FDA, ISO, EMA, Health Canada, and other regulating bodies secures you and your customers from costly regulatory and compliance mistakes. For more information visit: complianceteamllc.com.