Our quality approach to regulatory compliance

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

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.

When you partner with Agilex Biolabs, your project will be delivered by the experts and with the highest quality results.

At Agilex Biolabs, we deliver quality every time, for every project.

Study Rescue

Agilex Biolabs is a recognised leader in rescuing clinical trials from failure. We relish the chance to rescue the clinical trials that our competitors have deemed too difficult to execute.

We have successfully rescued clinical trials from failed assay, imminent FDA/EMA submission deadlines or the closure of competitors.

With access to the Australian Regulatory Framework and scientific experts with specialised expertise, we have successfully assisted our clients to meet tight deadlines and minimise costs.

Agilex Biolabs is the only bioanalytical facility in Australia to have successfully hosted an FDA Inspection.

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