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    Gap Analyses
    Gap Analyses

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

    Quality Systems Gap Analysis and Remediation

    A market leading medical device company with a robust pipeline of Class II and III surgical devices recognized challenges in quality and delivery in their clinical organization and requested an organization-wide gap analysis.
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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.

    Quick Response Needed for Cause Audit

    A small pharma company partnering with a government agency on a clinical program learned that FDA planned to inspect one of their top-enrolling clinical sites in conjunction with a significant finding for another sponsor.
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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.

    Warning Letter Remediation

    A global medical device company received repeat 483s and a Warning letter from the FDA. Halloran provided immediate expert regulatory and quality leadership overseeing interactions with the agency, remediation, and correction of 50+ findings.

Meet the Fix team leads

Paola Murphy
Managing Director
Jim Cassi
Senior Consultant
Todd Johnson
Principal Consultant
Brian Scogland, MS, MBA
Senior Consultant
Kathi Shah, MS, MBA
Principal Consultant
Mark Vermette
Principal Consultant