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Client Newsletter
The first newsletter exclusively devoted to FDA, ICH and GHTF compliance best practices, quality system advice, actionable regulatory intelligence, and cutting-edge product development strategies for biotechnology, pharmaceutical, and medical device executives.
"This should be mandatory reading for industry executives"
- Dan Michels, former FDA inspector
Latest Article
Device Company Environmental Controls: An Interview
October 11th, 2011Cerulean’s John Avellanet and FDA’s Kim Trautman interviewed on Environment Controls. FDA reminds device companies that they must control environmental conditions for both products and manufacturing facilities, or risk tough regulatory penalties. “Clearly environmental controls are important, and FDA will … Continue reading
Client Success Stories
“Cerulean was a true partner. John was instrumental in guiding the development of a FDA compliant quality system from ground zero in record time. This was accomplished in an environment of limited resources and rapidly changing processes. Through it all, he was a delight to work with and always brought more to the table than we were expecting.”
- Thomas Kerry McCarter, CEO, Newport News, Virginia
