Guidance Applied to Our Tailored Assay Services
At Agilex Biolabs, regulatory compliance is more than a requirement, it’s a cornerstone of our commitment to quality and integrity. Regulatory compliance is embedded in our tailored assay development, qualification, validation, and study analysis, ensuring alignment with international guidelines, industry standards, and your unique project requirements.
We apply a broad spectrum of regulatory frameworks, including:
Regulatory, Inspection and Accreditation History
Our world-class bioanalytical facilities in Australia are FDA-inspected and hold OECD GLP recognition through NATA, along with ISO/IEC 17025 accreditation, which ensure we have global credibility and trust.
We also meet independent assessment requirements for:
- Australian Code for the Care and Use of Animals
- Office of the Gene Technology (OGTR)
- ISO/IEC 27001 for robust information security
With over 20 years of regulatory excellence, Agilex Biolabs is proud to collaborate closely with our clients to meet their business and regulatory quality goals. Whether you’re preparing for inspection, navigating complex compliance landscapes, or seeking a trusted partner in bioanalysis, we deliver confidence, clarity, and compliance every step of the way.
