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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 Regulatory Submissions and Data Quality

April 24, 2015

To assess the integrity of a regulatory submission, US Food and Drug Administration (FDA) reviewers typically sample and then scrutinize 10% of the submitted data for data integrity issues. Clinical trial informed consent forms and financial disclosures, manufacturing batch or lot quality control review checklists, investigative drug inventory reconciliations, eCRFs, approved nonclinical study protocols versus […]

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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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