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Gap AnalysesGap 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.- Read more about Quality Systems Gap Analysis and Remediation
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Inspection Readiness & AuditsInspection 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.- Read more about Quick Response Needed for Cause Audit
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Compliance Consulting & RemediationCompliance 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.- Read more about Warning Letter Remediation
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Meet the Fix team leads
Laurie Halloran
Paola Murphy
Sheila Gwizdak