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    Gap Analyses
    Gap Analyses

    We mitigate risk by identifying areas of potential negative impact and providing actionable solutions.

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    Inspection Readiness & Audits
    Inspection Readiness & Audits

    Don’t panic! We ensure successful outcomes of inspections through training, storyboards, mock inspections, and audits.

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    Compliance Consulting & Remediation
    Compliance Consulting & Remediation

    When shit hits the fan, we partner with leadership to address clinical holds, product recalls, inspection failures, warning letters, court-ordered injunctions, and other material events.

Meet the Fix team leads

Joanna Engelke
Managing Director
Jim Cassi
Senior Consultant
Peter Ohanian
Principal Consultant
Mark Vermette
Principal Consultant