IND AI/ML credibility dossiers
Structuring defensible evidence packages under the FDA AI/ML framework for generative chemistry, ADMET prediction, and target validation.
Make computational claims defensible before they reach the clinic.
For CSOs, heads of computational R&D, and regulatory science leaders whose AI-derived candidates are advancing toward regulated development.
What makes this hard
Partners question the platform
AI discovery engines generate promising molecules, but pharma partners and investors question the reproducibility and regulatory readiness of the computational claims behind them.
Filings need boundaries, not benchmarks
FDA's credibility framework expects an explicit, bounded Context of Use for models that support regulatory decisions. An AUROC score is not a boundary.
Internal gates lack evidence standards
Candidate-progression decisions ride on computational predictions with no standardized audit trail a reviewer — or a board — can evaluate.
Where we engage
Compound ranking & candidate gating
Mathematical risk boundaries that prevent multi-million-dollar clinical progression of computationally flawed leads.
Partnering & licensing due diligence
Independent verification of platform claims for venture, M&A, and in-licensing sponsors — evidence that survives the data room.
Stop wasting clinical trials on unverified computational predictions. Bind your models to defined biological operating envelopes.
The pillars doing the heavy lifting here
Trust Records & Audit Ledger
Electronic records structured for 21 CFR Part 11 discipline and audit-readiness.
Continuous Validation Engine
A cheaper or newer route must earn its traffic with empirical evidence.
Runtime Boundary Enforcement
Out-of-boundary use is rejected at runtime — the Context of Use is enforced, not just documented.
Framework anchors
FDA AI/ML Credibility FrameworkFDA DDT Qualification21 CFR Part 11NIST AI RMF 1.0
Every engagement is structured in the evidentiary language these frameworks expect — so the work survives reviewer scrutiny, not just internal approval.
Bring us one candidate-gating decision.
A twenty-minute boundary conversation on one active candidate or platform claim — where the evidence supports confidence, and exactly where it stops.
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Prefer to see the work first? Walk through an eight-week pilot, step by step