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Cerulean Associates LLC

United States


Cerulean is a small, boutique consulting firm specializing in simplifying and streamlining FDA, ICH and IMDRF quality systems and regulatory compliance. We offer a bi-monthly FDA compliance newsletter of best practices and intelligence, FDA compliance seminars and workshops, mock FDA inspections, data integrity and Part 11 expertise and auditing, and FDA records management & retention help. Read client testimonials, workshop attendee reviews, published articles and interviews online at

Areas of subspecialty

483 responses
Warning Letter Responses
Remediation Strategies
Labeling and Website Reviews
Audits and Gap Analyses
Mock FDA Inspections
Regulatory Submissions
Areas of service
  • North America