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  • Welcome to Myers Quality Consulting

Resources

  • FDA Website
  • Good Clinical Practice in FDA-Regulated Clinical Trials
  • Compliance Program 7348.001 Bioresearch Monitoring: Human Drugs In Vivo Bioequivalence
  • Compliance Program 7348.808 Bioresearch Monitoring: Good Laboratory Practice
  • Compliance Program 7348.809 Bioresearch Monitoring: Institutional Review Board
  • Compliance Program 7348.810 Bioresearch Monitoring: Sponsors, Contract Research Organizations and Monitors
  • Compliance Program 7348.811 Bioresearch Monitoring: Clinical Investigators
  • ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports
  • ICH E6: Good Clinical Practice: Consolidated Guidance

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