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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

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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

Cerulean helped us understand all of the regulatory and operational considerations involved in retaining the right records. John did a great job, going above and beyond to help us see the risks we were running, draft practical policies, and suggest ways to improve while putting in a reasonable and defensible document management program of policies, procedures, and FDA records retention schedules.

- General Counsel, Medical Device Company, Washington, D.C.

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