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Zebrafish genetic variants with a full functional physiology analyzed by AI hardware.
Know early, Make decisions early !

FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development -March 18, 2026​
​​The 4 Validation Principles for Submission Criteria
Context of Use
Defines the exact scientific question the NAM answers (e.g., assessing hepatotoxicity during clinical trials or setting safe starting doses).
Human Biological Relevance
Requires sponsors to justify cell types, species of origin, and physiological features to prove the model mirrors human in vivo toxicity.
Technical Characterization
Demands rigorous documentation of assay parameters, limits of detection, reference compound controls, and sources of batch variability.
Fit-for-Purpose
Assures the data can directly drive regulatory drug reviews, either as a standalone alternative or within a broader total weight-of-evidence package.
Read how we drive change in your candidate development process
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