Regulatory & Compliance Field Guide
Navigating FDA, CDC, and HHS regulatory affairs
Executive summary
A condensed reference for contractors and program leads working across FDA, CDC, and HHS — covering policy compliance, documentation expectations, and the common audit findings that derail awards.
The regulatory map
FDA, CDC, and HHS each carry distinct review cultures. Understanding the unwritten norms is as important as knowing the CFR sections.
Policy compliance essentials
What 'compliant' actually means in practice: traceable decisions, signed reviews, archived evidence, and a defensible chain of custody.
Top ten audit findings
Drawn from extensive pre-award and post-award review experience. Most are preventable with three weeks of housekeeping.
Documentation that survives an audit
Templates and conventions for policies, SOPs, and decision memos that hold up under inspection.
When to escalate to counsel
Clear triggers for engaging legal — and the artifacts to bring with you when you do.
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