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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

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'd received multiple 483s from an FDA inspection and lacked the resources to quickly solve the issues. Cerulean conducted a gap analysis, created a practical roadmap for resolution, and then helped lead our internal team to collaboratively drive the roadmap to success in 3 months. As a result, we landed two new multi-million dollar projects.

- RA & Quality Management Director, Pharmaceutical CMO, Boston, Massachusetts

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