Sign up  

LMT Consulting LLC

Contact:  Laurie M. Taddonio, President
Specialty: Devices, New Drugs/OTC, Biologics/Biotechnology

Laurie is an independent consultant with 25+ years of experience in the FDA-regulated industry, including 10 years with the FDA as a Bioresearch Monitoring Specialist Investigator, Bioresearch Monitoring Program Manager, International Inspection Team member, and instructor and manager of FDA’s New Investigator and Analyst Training. Laurie has been a consultant 15+ years and specializes in assisting pharmaceutical and medical device companies internationally with quality assurance and compliance. Her expertise includes clinical quality systems assessments and consulting, SOP evaluations and writing, training, mock FDA inspections, preparation for FDA inspections, assistance during FDA inspections, investigations of suspected fraud and scientific misconduct, and QA audits of sponsors, CROs, clinical investigators, and IRBs. She has worked on projects ranging from simple audits to complex criminal investigations and has proactively helped companies achieve successful outcomes in obtaining product approvals as well as assisted companies in response to FDA 483s, Warning Letters, Integrity Holds, Application Integrity Policy (AIP), and Consent Decree.

Years in business: 25+


 phone 949-813-1938 
 alt  This email address is being protected from spambots. You need JavaScript enabled to view it.