Company
Regulatory-grade quality, by design.
iNGENū’s quality system is built for data that stands up to the FDA, EMA and MHRA — with physician oversight and continuous, risk-based self-audit at its core.
ICH-GCP E6(R3)
Every trial is conducted to the latest International Council for Harmonisation Good Clinical Practice guideline.
FDA-ready data
Built to 21 CFR 312.120 so Australian data is acceptable to the FDA — plus direct submission via the FDA e-gateway. Data is also accepted by the EMA and MHRA.
TGA CTN / CTA
Regulatory pathways through Australia’s Therapeutic Goods Administration, including the CTN scheme that can approve first-in-human trials in as little as ~4 weeks.
21 CFR Part 11 & GAMP 5
Computerised systems are GAMP 5 validated with Part 11-compliant audit trails and electronic signatures.
Continuous self-audit
A risk-based, continuously self-audited quality management system — quality is monitored in real time, not just at close-out.
Pharmacovigilance
In-house medical monitoring and safety management across the full study lifecycle.
Data your regulator will accept
Talk to us about building an FDA-ready evidence package for your programme.
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