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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.

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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

We commissioned Cerulean's services to develop our knowledge and internal expertise. John Avellanet delivered against this objective and then some. John kept our objectives front of mind in every conversation and deliverable he made. He also considered our objectives as a baseline, consistently delivering more than was documented and expected.

- Gordon Russell, President, & Simon Elleway, Director, Dedham, Massachusetts

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