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The first newsletter exclusively devoted to FDA, ICH and IMDRF 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
What exactly qualifies an app as a medical device? The healthcare industry has been waiting for a little more clarity on this issue ever since the FDA said it would regulate medical apps that can be used as an accessory … Continue reading
Client Success Stories
“Cerulean's John Avellanet took the bare bones of a document retention need, and applied the FDA regulations, the EMA rules, and the ISO guidelines to the daily realities of our business. With John's help, we were able to develop a top-notch records retention policy and matrix that actually sticks, providing needed benefits for years to come. We could not have been happier with Cerulean's work product, professionalism, or positive attitude throughout the project.”
- Leslie Wood, Associate General Counsel, Leesburg, Virgina