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Solve compliance problems, lower costs & reduce risk with trusted consulting and training to streamline
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

Cerulean's John Avellanet took the bare bones of a document retention need, and applied the FDA regulations, the EMA rules, and the ISO guidelines to the daily realities of our business. With John's help, we were able to develop a top-notch records retention policy and matrix that actually sticks, providing needed benefits for years to come. We could not have been happier with Cerulean's work product, professionalism, or positive attitude throughout the project.

- Leslie Wood, Associate General Counsel, Leesburg, Virgina

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