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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.

Prefer a “go-slow” approach?

Lean quality systems

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

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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

Cerulean helped us understand all of the regulatory and operational considerations involved in retaining the right records. John did a great job, going above and beyond to help us see the risks we were running, draft practical policies, and suggest ways to improve while putting in a reasonable and defensible document management program of policies, procedures, and FDA records retention schedules.

- General Counsel, Medical Device Company, Washington, D.C.

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