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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

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