LMT Consulting specializes in assisting pharmaceutical and medical device companies internationally with GCP quality assurance and compliance. Services include, but are not limited to, clinical quality systems assessments and consulting, SOP evaluations and writing, training, mock FDA inspections, preparation for FDA inspections, assistance with FDA regulatory actions, investigations of suspected fraud and scientific misconduct, and QA audits of sponsors, CROs, clinical investigators, and IRBs. We work on projects ranging from simple audits to complex criminal investigations. We proactively help companies to achieve successful outcomes in obtaining product approvals as well as assist companies in response to FDA 483s, Warning Letters, Integrity Holds, Application Integrity Policy (AIP), and Consent Decree. Laurie M. Taddonio, President of LMT Consulting, is a GCP specialist with more than 20 years of combined FDA and industry experience.
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