Reduce complexity and optimize compliance

With lean compliance techniques, you can streamline your quality system, ensure FDA data integrity, and retain the right FDA records to prove compliance, product safety and product efficacy. Improve your productivity, improve cost-efficiency, and improve compliance. Balance business realities with compliance in a cost-effective, common sense way with Cerulean.

Real-World Results

• Reduce SOP overhead and re-training by 35%
• Gain at least 130 hours of improved productivity each year
• Eliminate FDA-483 findings and prevent warning letters
• Increase revenue by up to 7% annually
• Strengthen data integrity and FDA recordkeeping controls
• Save up to $19,500 annually per employee
• Cut time-consuming CAPAs by at least 12%
• Pass FDA, Health Canada, EMA and other regulatory inspections
• Ensure compliance with FDA, ICH, IMDRF and ISO quality systems

Cerulean provides expertise to help you reduce overhead, strengthen your compliance, and ensure data integrity from pre-clinical to post-market

Read specific client success stories. See our pricing levels and guarantees.

Which Cerulean Service is Right for You?

• Mock FDA audit and gap analysis
• Onsite or remote corporate workshops and compliance training
• Expert lean compliance consulting
  • SOP streamlining and process mapping workshops
  • FDA data integrity controls and data integrity audits
  • Recordkeeping, document & FDA records retention programs
• Litigation support and independent IRO services for consent and corporate integrity agreements

Get a competitive edge – Contact Cerulean today

Learn more about Cerulean and our exclusive client benefits. Or take your time and read media interviews and case studies about cost-effective, defensible compliance.