Quality assured preclinical & clinical testing solutions

Regulatory Compliance

Quality System
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)

TetraQ's accreditation includes accredited ELISA testing in its services to Australian and international biopharmaceutical organisations.

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 TetraQ's facility. TetraQ has been audited by clients and authorities.

NATA
The Australian National Association of Testing Authorities (NATA) is the oldest laboratory accreditation body in the world.

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TetraQ Capabilities

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TetraQ - Birds Eye View

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Technical infrastructure

Information about the laboratories and technical infrastructure More...

REACH

TetraQ has experience in supporting clients to meet the REACH requirements More...

Quality System

TetraQ operates within a quality framework in compliance with international standards More...

Fact Sheets

TetraQ Capabilities

Overview of Capabilities and Services

More...

TetraQ - Birds Eye View

A one-page overview of TetraQs services and capabilities

More...
All Factsheets