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FDA compliance & strengthen your data integrity
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Upcoming Events

Join Cerulean's John Avellanet at these upcoming cGXP training workshops, webinars, and conferences. Sessions include data integrity, supplier quality oversight, FDA recordkeeping, quality system best practices, and preparing for inspections from FDA, EMA and ISO.

"Simply put, John Avellanet is the best in the business. Period."
- N. Singer, former US DOJ and FDA prosecutor

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Latest Article

FDA’s New Inspection Protocol Begins to Have Impact

December 20, 2016

The FDA’s New Inspection Protocol Project (NIPP) is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current average of 30 percent to a target of 50 percent. “As a pharma company if you’re going to submit a new drug, instead of a 30 percent chance of getting […]

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Client Success Stories

We selected Cerulean Associates because of their level of experience, credibility, and specifically their expertise with FDA, manufacturing and records. Their work really helped our executive team see the need for good recordkeeping, put in place a straightforward framework, and provide definitions and examples that answered all our questions - and that we refer to even today. John Avellanet of Cerulean is a no-nonsense expert and will help any company achieve rapid results in the most cost-effective way possible.

- - Luanne Lochner, Records Management Chair, Baraboo, Wisconsin

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