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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
“John truly shares his expertise and knowledge with you. During an audit we conducted together last year, he regularly gave the client practical and unbiased recommendations, making sure the focus was always on their ability to succeed, not just comply.”
- Jackie Cassada, President, Nottingham, England