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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

John's approach to Part 11 compliance was skillful in emphasizing how pharma and biotech companies can balance bottom lines to align with FDA expectations. He demystified the technical concepts of Part 11 and translated them into real-world best practices to help us manage patients' safety, rights, and data integrity.

- - Mai Nguyen, Senior Manager, R&D Quality and Compliance, Boston, Massachusetts

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