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Client Newsletter

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.

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- Dan Michels, former FDA inspector

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Latest Article

Rapid FDA Recordkeeping

September 12, 2014

FDA is citing firms more and more for inadequate recordkeeping and record retention. From electronic recordkeeping systems to all paper to a hybrid reality, firms need to manage their documents and emails and records to ensure compliance without risking greater liability and causing greater cost. “Keeping everything” is no solution – and going it alone […]

Client success stories

John Avellanet at Cerulean came to our rescue. We started as a small medical device supplier to the US Defense industry and quickly grew into a company with over twenty products. Our processes were not keeping up with our growth. When we received a warning letter from FDA, John was there for us. He guided us through the process of bringing us compliant with the QSR and cGMPs, and helped us through the follow-up FDA inspection. Cerulean was there for us from start to FDA closeout letter.

- - Paul Harder, President, Gloucester, Virginia

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