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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 helped us understand all of the regulatory and operational considerations involved in retaining the right records. John did a great job, going above and beyond to help us see the risks we were running, draft practical policies, and suggest ways to improve while putting in a reasonable and defensible document management program of policies, procedures, and FDA records retention schedules.

- General Counsel, Medical Device Company, Washington, D.C.

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