Regulatory Insight

Strategic Compliance

As a former FDA compliance leader, I provide medical device and pharmaceutical companies with direct, strategic guidance. My boutique approach ensures personalized insight to overcome critical regulatory hurdles. I can support effective preparation for inspections, decisive 483 and warning letter remediations, and robust quality system enhancements that drive sustainable compliance.

Inspection Readiness

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Enforcement Strategy

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Proactive Compliance Solutions

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Warning Letter Remediation

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483 Responses

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Regulatory Guidance

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Inspection Readiness | Enforcement Strategy | Proactive Compliance Solutions | Warning Letter Remediation | 483 Responses | Regulatory Guidance |

Our Core Regulatory & Compliance Services

  • Risk assessment for regulatory compliance

    Compliance Assessment

  • Image of Mock FDA inspections with former investigator

    Mock FDA Inspections & Coaching

  • FDA inspection backroom support

    FDA Inspection Support

  • 483 response strategy and remediation support

    FDA 483 Response Strategy

  • FDA Warning Letter Remediation Support

    Warning Letter | Untitled Letter Responses

  • Conference room Regulatory Meeting FDA

    Regulatory Meeting Preparation & Guidance

  • FDA Recall Guidance Medical Devices

    FDA Recall Guidance

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Ready to Transform Your Compliance Strategy?

With decades of insider FDA knowledge, Jessica Mu Consulting, LLC offers the unique “both sides of the fence” expertise you need. Let’s discuss your challenges and explore a proactive path forward.