John Avellanet

John Avellanet

Managing Director & Principal, Cerulean Associates LLC

is an award-winning FDA data integrity compliance expert known for his business-savvy, pragmatic advice and engaging, friendly style.
Mr. Avellanet was the industry expert reviewer for the international standard, Evidential Weight and Legal Admissibility of Electronic Information (BSI 10008), and serves as a lead expert in the ISPE’s Data Integrity working group.
He has trained regulatory agency officials on advanced inspection tactics for data integrity, and routinely offers public workshops on data integrity best practices as well as more private, customized data integrity training to clients around the world.
In 2014, Mr. Avellanet co-authored the book, Pharmaceutical Regulatory Inspections along with several current and former regulatory agency officers from Health Canada, WHO, MHRA, and EMA. He was the lead author of several cGMP regulatory certification courses for the US Regulatory Affairs Professional Society (RAPS).
In 2011, Mr. Avellanet was asked by the US Department of Justice and the US Office of Inspector General, Health & Human Services, to oversee the multi-million-dollar Dr. Comfort Corporate Integrity Agreement (CIA) through 2016.
His industry classic book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, was originally featured at BIO 2011. In both 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 10 years, he has been interviewed on public radio programs, in numerous industry magazines and multiple international news outlets. He has written more than 100 different articles on cost-effective FDA compliance, many of which have been translated and syndicated around the world.
Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, Mr. Avellanet was a former Fortune 50 combination drug and device C-level executive who created, developed, and ran his company’s compliance programs for ISO, DEA, BIS and FDA compliance. During his career, he has had to defend decisions to investigators, auditors, and litigators alike. He now brings his hard-won, real-world expertise and practical advice to corporate clients worldwide.