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John Avellanet is an award-winning FDA compliance expert.

He serves as the IRO for a major consent decree, is the lead author of several certification courses for the US Regulatory Affairs Professional Society, and has recently published the book Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (Logos Press).

In 2009 and 2011, Mr. Avellanet won the “Best of Business” award from the US Small Business Commerce Association. His blog, ComplianceZen.com, has been repeatedly named one of the “Top 50 Blogs” worldwide on FDA compliance issues.

Over the past 6 years, he has been interviewed on public radio programs and in numerous industry magazines. He speaks frequently for industry conferences and corporate workshops.

Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, Mr. Avellanet was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance. During his career, he had to defend decisions to investigators, auditors, and litigators alike. He now brings all of that hard-won, real-world experience and practical advice to his corporate clients worldwide. To date, he has saved his clients an average of $1.2 million each and kept them out of trouble with FDA, EMA and other regulatory agencies.

A former US Department of Justice prosecutor has said of Mr. Avellanet, “He is the best in the business. Period.”