Regulatory Compliance

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Regulatory Compliance

Guidance Applied to Our Tailored Assay Services

Our tailored assay development, qualification, and validation are performed according to international regulatory guidelines, industry standards, and project specific requirements.

  • OECD Good Laboratory Practice (GLP)
  • ICH E6 Good Clinical Practice (GCP)
  • WHO Good Clinical Laboratory Practice (GCLP)
  • ICH M10 Bioanalytical Method Validation
  • ISO/IEC 17025
  • ISO/IEC 27001 Information Security Management System
  • FDA 21 CFR Part 11
  • Data Integrity Principles – ALCOA++
  • Industry White Papers

Regulatory, Inspection and Accreditation History

Our world-class FDA inspected bioanalytical facilities in Australia have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

As well as meeting requirements through independent assessment for:

  • Australian Code for the Care and Use of Animals
  • Office of the Gene Technology (OGTR)
  • ISO/IEC 27001 – Information Security Management Systems

Agilex Biolabs is proud of its over 20 years of regulatory compliance, and is committed to collaborating with our customers regarding their business and regulatory quality requirements.