Technology

The science is ready.
The regulators agree.

The FDA Modernization Act 2.0 explicitly enables non-animal testing methods. Azunic's platforms already run the five-step pipeline that FDA reviewers expect to see.

01
Input
Compound intake & SMILES parsing
02
AI model
In silico ADMET prediction
03
AI model
Organoid panel screening
04
AI model
Mechanistic pathway analysis
05
Output
Regulatory-grade dossier output
Time to Results

12–16 weeks

Compressing what used to take years of animal studies into a fraction of the timeline.

Validation

Proven against legacy methods

Peer reviewed
82%
sensitivity

DILI Retrospective Study

Across 847 compounds with known human hepatotoxicity outcomes. Reference dataset: DILIrank.

OECD TG 442
79%
specificity

Renal Toxicity Panel

Against clinical nephrotoxicity signals from post-market surveillance data across 12 drug classes.

ICH S7B
91%
concordance

Cardiac Safety (hERG)

Head-to-head comparison with patch-clamp gold standard on 200 compounds. ICH S7B aligned.

Regulatory Confidence

Built to satisfy the people who sign off on your filing.

The FDA Modernization Act 2.0 (2022) removed the animal testing mandate from US drug applications. EMA and PMDA are aligned, and ICCVAM actively promotes NAMs. Every Azunic dossier is structured to match what these reviewers already expect to see.

FDA Modernization Act 2.0Active (2022)
ICH M7 / S7A / S7BFull compliance
OECD Test Guidelines (NAM)Aligned
ICCVAM Recommended MethodsApproved list
EMA Guidance on NAMsUnder implementation
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Ready to leave animal testing behind?

Speak with our scientists. Get an assessment of your compound against our NAM platform.