Compliance Zen is published John Avellanet, the co-founder and Managing Director of Cerulean Associates LLC, a small, private advisory firm providing independent expertise on lean FDA quality systems compliance to executives in the life sciences.  The thoughts and ideas in this blog and my postings are strictly my own.  Posts on this blog are my personal opinions and do not necessarily represent the views of Cerulean Associates LLC or its clients.


About the Author

I’ve written over 100 articles, publish the FDA intelligence and quality systems strategy newsletter, SmarterCompliance, serve as the FDA compliance columnist for both the Journal of Commercial Biotechnology and Pharmaceutical Processing magazine, and was a contributing author to the book Best Practices in Biotechnology Business Development: Valuation, Licensing, Cash Flow, Pharmacoeconomics, Market Selection, Communication, and Intellectual Property (Logos Press).  I’m currently working on a book about the regulatory and quality systems challenges in the landscape of personalized medicine.

I speak frequently at industry events, business schools, and corporate workshops, and meet often with regulatory officials.  You can find a list of my recorded seminars on the Cerulean website.

To contact me about speaking for your event, your company, or conducting an online presentation for you, just contact me through the Cerulean website or its “speaking and workshops” sub-page:  http://www.ceruleanllc.com/Speaking.htm

I grew up in Alexandria, Virginia, right across the Potomac river from Washington, D.C.  I earned my Bachelor’s at the College of William & Mary in Virginia and my Master’s degree at the University of Kansas.  Today, after many, many years of commuting 2+ hours a day, I’m fortunate enough to now work from my home in Williamsburg, Virginia.

You can learn your fill about my career and regulatory experiences here on the Cerulean website:  http://www.ceruleanllc.com/About/John_Avellanet.htm


Whether you agree or disagree with my compliance philosophy, opinions and suggestions, please share your thoughts on this blog or contact me directly through the Cerulean website (http://www.ceruleanllc.com).  I look forward to hearing from you!




Compliance Zen is published for informational purposes only; it contains no legally-binding advice whatsoever. Compliance Zen is intended primarily for other compliance professionals and executives in the pharmaceutical, biotechnology, medical device and diagnostic industries. Information in this blog draws on a variety of sources, including published reports, interviews, personal experiences, and research, which may or may not have been prepared or conducted by Cerulean Associates LLC ("Cerulean"). Cerulean does not warranty the accuracy of the information contained on Compliance Zen.  Contents of Compliance Zen should not be considered as legal advice, legal opinion, or expert opinion on specific facts and circumstances. No part of Compliance Zen – whether information, commentary, or other –  may be attributed to Cerulean's clients. Readers should be aware that Cerulean represents many companies in the life sciences industries, and therefore Compliance Zen may occasionally report on news of specific relevance to Cerulean clients. Compliance Zen will always strive to be unbiased in its reporting. All information on Compliance Zen should be double-checked for its accuracy and current applicability; information on this blog should never be the sole basis upon which decisions are made. Cerulean assumes no liability for actions taken or not taken as a result of the information on Compliance Zen.


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