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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

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 provided us with intelligent regulatory guidance that allow our business to showcase its compliance and remain competitive within our industry. They understood our objective and did not try to sell us other compliance consulting services.

- - J. Balcerzak, Director of Organizational Development & Quality, East Hartford, Connecticut

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