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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

More FDA-483s and Warning Letters Show Need to Boost Supplier Controls

April 21, 2014

Medical device manufacturers saw an increase in 2013 in the number FDA-483 observations that cite inadequate supplier controls. Poor supplier control is one of the top five most common 483 citations for devicemakers, and is an issue that has been gaining steam with FDA investigators and EMA inspectors for years. In 2010, 84 FDA-483 citations […]

Client success stories

John Avellanet provides excellent advice that is both compliant and reasonable. He also works within the constraints of a company’s business realities when providing advice. This has helped integrate the controls into our company much faster and for a lot less; with our small staff and low budget, this has been extremely helpful. I would recommend Cerulean for small to mid-size firms that need to be in regulatory compliance with the FDA and want to get to market (or partnership) quickly.

- Michael Weber, Director of Quality, Williamsburg, Virginia

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