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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

We selected Cerulean Associates because of their level of experience, credibility, and specifically their expertise with FDA, manufacturing and records. Their work really helped our executive team see the need for good recordkeeping, put in place a straightforward framework, and provide definitions and examples that answered all our questions - and that we refer to even today. John Avellanet of Cerulean is a no-nonsense expert and will help any company achieve rapid results in the most cost-effective way possible.

- - Luanne Lochner, Records Management Chair, Baraboo, Wisconsin

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