Quality systems

Accredited facility and systems which comply to strict regulatory and industry standards.

  • 360biolabs complies with the requirements of ISO/IEC 17025 (2005) and ISO/IEC 15189 (2012) interpreted for research using the CITAC Guide CG2 Quality Assurance for Research and Development and Non-Routine Analysis (1998)
  • Management of projects is conducted in accordance with the OECD Principles of Good Laboratory Practice
  • ICH/FDA/EMA compliant assay validation process

  • Industry standard FDA-compliant reports
  • Robust protection of customer IP
  • World-class facilities including BSL-2, BSL-3 & quarantine labs secured with continuity fail-safes
  • Consultancy on the development of Quality Management Systems and the conduct of independent external audits