FDA Records Retention & Compliance

Designed exclusively for FDA-regulated firms

Cerulean’s advice draws upon career experiences building & running records management departments, defending decisions to inspectors and litigators … and being hired by outside counsel to scrutinize and tear down the programs of others.

Cost-Effective, Flexible Solutions

We can show you how to define and document your product lifespan to minimize your liability under FDA record-keeping requirements.


Need an independent snapshot of your records retention and compliance status…?  See our Mock FDA Audit and Gap Assessment service.

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Email Cerulean today. We offer a free half hour consultation to new clients