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      Contact Info

      Phone:

      Main - 949-461-0527

      Fax - 949-461-0528

      Address:
      27068 La Paz Rd # 527 Aliso Viejo, CA 92656
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      Category
      Pharmaceutical Consultants
      Services / Products
      Laurie M. Taddonio, President of LMT Consulting, is a GCP specialist with more than 20 years of combined FDA and industry experience providing you:Balance between your regulatory & business needsEffective & sustainable solutionsEfficient, economical serviceProfessional, high-quality productsLaurie will work with you to develop a plan that accomplishes your goals by focusing specifically on what you need. Quality is what you should expect from your consultant and what you deserve. Furthermore, she believes it is vital to create a positive experience that your company can embrace and learn from. Laurie takes pride in being part of the team and helping you to achieve your success.Laurie has more than 20 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. She was also a Regulatory Affairs Specialist and Manager in the pharmaceutical/medical device industry before beginning her consulting career. She is a presenter to professional and trade organizations and a member of the Regulatory Affairs Professionals Society (RAPS), Society of Quality Assurance (SQA), and Orange County Regulatory Affairs Discussion Group (OCRA).LMT Consulting specializes in assisting pharmaceutical and medical device companies internationally with 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.For more information about our services and qualifications, please contact us.
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      Data provided by one or more of the following: Thryv, Data Axle, Yext.