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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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Latest Article

Data Integrity Training

August 26, 2014

FDA’s emphasis on data integrity and electronic record compliance causes anxiety, confusion and frustration. What is “data integrity” as it relates to day-to-day activities? to data entry versus data review and manipulation and reporting? to data transmittal from one system to another? to data archives of historical records? And who is responsible for data integrity?  […]

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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