© CERULEAN ASSOCIATES LLC

Solve compliance problems, lower costs & reduce risk with trusted consulting and training to streamline
FDA compliance & strengthen your data integrity
.
Find out how →

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

See the schedule Request Training

Latest Article

Rapid FDA Recordkeeping

September 12, 2014

FDA is citing firms more and more for inadequate recordkeeping and record retention. From electronic recordkeeping systems to all paper to a hybrid reality, firms need to manage their documents and emails and records to ensure compliance without risking greater liability and causing greater cost. “Keeping everything” is no solution – and going it alone […]

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

Read more success stories