Translational NAMs qualification
Readiness and validation standards for microphysiological systems and organ-on-chip platforms under OECD GD 34.
Qualification-grade evidence for methods that replace animal testing.
For federal programs, consortia, and translational science teams establishing readiness standards for New Approach Methodologies.
What makes this hard
No shared evidentiary bar
Alternative methods lack standardized qualification benchmarks and evidence frameworks that hold across participating laboratories.
Reproducibility across sites is unproven
A method that performs in one lab must demonstrate cross-laboratory reproducibility before it can anchor a regulatory pathway.
Translational readiness is asserted, not scored
Programs need structured readiness assessment before committing qualification resources to a method.
Where we engage
Evidence standards authoring
Structured, non-compensatory evidence frameworks that participating labs can actually execute against.
Cross-laboratory benchmarking
Comparator design and reproducibility verification across sites, instruments, and reagent batches.
Celbridge serves as a performer on the NIH Common Fund Complement-ARIE program, providing translational readiness assessment within the NAMs Reduction to Practice Challenge.
The pillars doing the heavy lifting here
Portfolio Command Center
Leadership sees the whole AI portfolio through evidence, not dashboards of vanity metrics.
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.
Framework anchors
OECD GD 34FDA Modernization Act 2.0ISO/IEC 23894NIST 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.
Discuss translational readiness for your program.
A briefing on translational readiness scoring and cross-laboratory reproducibility standards for microphysiological systems under OECD GD 34.
or write to [email protected]
Prefer to see the work first? Walk through an eight-week pilot, step by step