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Specialized Compliance Consulting Services

In addition to our FDA coaching and advisory program for corporate executives, the SmarterCompliance™ program, we have several specialized services.

 

Select the Result You Want

• FDA compliance assessment, certification and report

  • Need an independent snapshot of your FDA compliance status...?  Or proof of compliance to give a third-party?  See our Mock FDA audit service.

• Intellectual property security review

  • Are you entering a development partnership, merger, or outsourcing your manufacturing and/or R&D...?  See our intellectual property security audit.

• Cost-efficient quality systems & compliance

  • Lean FDA quality systems (GLPs, GMPs, QSRs, plus ICH and GHTF standards)

  • IT compliance (revised Part 11 and Annex 11)

  • Quality by design implementation or improvement

  • FDA records management and litigation discovery

• Rapid, expert response to FDA inspections, 483 observations, or warning letters

We work with what you have to accomplish your goals

 

Make sure to take a look at our FAQs, pricing models, our client successes, and our satisfaction guarantee to see for yourself why clients choose Cerulean.

 

What To Do Next

Contact us today.  We offer a FREE ½ hour consultation to new clients.