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 FDA compliance status? Or an audit inspection of your critical suppliers? See our Mock FDA audit service.

Fix a previous consultant’s work

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

Supplier management help

Get control of suppliers, ensure compliance with quality agreements and regulatory requirements, and put in place an FDA-approved supplier qualification and oversight process

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

Lean quality systems & compliance

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FDA recordkeeping

  • FDA records retention for GMPs, GLPs, GCPs and QSR
  • Consolidate regional, US and international record requirements
  • Defensible documentation
  • Conformity with FRCP & FDA Part 11 rules for e-records

Part 11 & Data Integrity

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Client Success Story

Investor pressure is on for us to streamline our compliance activities and reduce overhead. And yet we still have to abide by FDA, EMA, MHRA, and dozens more regulatory health agencies. We struggled to bridge where we were versus where we needed to go. Mr. Avellanet came in, gave us a realistic plan we could all agree to, and in four months, we were finally on our way after nearly two years of struggling internally and with other consultants. Cerulean truly brings the insights and practical experience needed.

- Regulatory Affairs Senior Director, Multi-National Pharmaceutical Company, Iselin, New Jersey

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