Specialized Consulting Services

Practical advice, proven strategies and experience-based insights – approved by FDA investigators – to reduce risk, lower costs & improve your compliance

FDA compliance assessment

Need an independent snapshot of your compliance? Or an audit of your data integrity controls and plan?  See our Mock FDA audit service.

Lean quality systems & compliance

Part 11 data integrity

FDA recordkeeping help

Fix a previous consultant’s work

It’s “buyer beware” when hiring a consultant. Cookie-cutter SOPs, too many shortcuts and sloppy knowledge transfer leave you at risk.  Review our one year triple guarantee.

Litigation support

Forced to show how your SOPs & policies maximized safety and regulatory compliance? Or need expert FDA compliance help to build a case? Or need to find a well-respected, and known corporate integrity agreement IRO? See our Litigation support services

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Why should I hire Cerulean versus another consulting firm?