TetraQ operates within a quality framework in compliance with the following international standards:

• OECD Principles of Good Laboratory Practice (GLP)
• ISO 17025 (R&D) accreditation
• FDA Good Laboratory Practice for Nonclinical Laboratory Studies (21CFR58)
• FDA Electronic Records; Electronic Signatures (21CFR11)

With its world recognised credentials, TetraQ has established a strong reputation for quality. We are the only Australian preclinical service provider to include accredited ELISA testing in its services to Australian and international biopharmaceutical organisations. We welcome client sponsored audits.

GLP compliance ensures that data from relevant preclinical studies will be accepted for international regulatory review e.g. FDA. This is a consequence of the Australian GLP monitoring body, NATA (National Association of Testing Authorities), being a signatory to an international agreement for the mutual acceptance of data.

ISO 17025 (R&D) accreditation recognises the technical competency of our facility.

As part of the process of compliance and quality improvement, our facilities and studies undergo regular internal and external audits.

Following recent quality system updates, we can now conduct GLP studies that are compliant with the FDA Code of GLP (21CFR58).

For further information on our quality credentials, please refer to the NATA website, www.nata.asn.au and enter ‘tetraq’ under ‘Keywords’.