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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

John's approach to Part 11 compliance was skillful in emphasizing how pharma and biotech companies can balance bottom lines to align with FDA expectations. He demystified the technical concepts of Part 11 and translated them into real-world best practices to help us manage patients' safety, rights, and data integrity.

- - Mai Nguyen, Senior Manager, R&D Quality and Compliance, Boston, Massachusetts

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