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Quality

Globally Recognised Accreditation

Team of scientists working in a bioanalytical laboratory
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360biolabs
Commitment
to Quality

At 360biolabs, our dedication to quality is unwavering. With a focus on precision and compliance with international quality benchmarks, our analytical testing services prioritise meticulous attention to detail. Our method development and validation procedures align with global scientific regulatory frameworks such as FDA, EMEA, and ICH, ensuring adherence to stringent standards.

 

Australian Advantage

Regulatory bodies

360biolabs follows global scientific regulatory bodies such as NATA, ICH, OECD, EMA, FDA

Quality Systems

360biolabs is accredited by Australia’s National Association of Testing Authorities (NATA) for compliance with the requirements of Good Laboratory Practice (GLP), as well as Good Clinical Laboratory Practice (GCLP) and ISO/IEC 17025.

NATA operates a cycle of accreditation with assessment visits conducted regularly for ongoing compliance.

360biolabs implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems that are involved in processing data.

Our Team Delivers Excellence in Quality

Our quality team is responsible for providing an effective and efficient system and regulatory counsel for our operational units, addressing QA aspects related to our science, technologies, information, and services cohesively.

Quality operates independently from these operational units and regularly performs quality review activities (e.g., process/facility inspections and vendor audits) to ensure compliance with appropriate regulatory regulations.

Our Approach
Scientist working in a GCLP, GLP and ISO17035 Laboratory from a QA issued SOP to ensure the reproducibility and quality of data

Our commitment to quality—along with our unrivalled scientific expertise and technologies—allows us to provide our partners with the confidence of the most accurate, precise, and comprehensive high-quality bioanalytical testing services—with integral results that are delivered right on time and right the first time.

Alistair Draffan's profile picture

Alistair Draffan, PHD

President at 360biolabs
Sample management team receiving samples, accessioning into LIMS, storing in 24/7 temperature monitored facility. Integrity of every sample counts

Enabling future medicine together. Contact our team today to start your next early-phase clinical trial.

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