What it checks.
BryNaxa CMC Reconciler verifies that every number agrees across a CMC submission — the Module 3 and QOS narrative, specification tables, certificates of analysis, stability tables, and batch data.
It reads each source and flags every value that doesn’t reconcile, deterministically, so a transcription mismatch is caught before a reviewer finds it.
Where it fits in the workflow.
Regulatory and CMC authors assembling a submission from many source documents. Run it before the package goes out to catch every number that disagrees across the dossier.
Everything stays on your machine.
Runs fully offline on your own Windows computer. No account, no cloud, no telemetry — your files never leave the desk. Every result comes from a published method computed the same way every time, so the same input always produces the same findings. You keep the report as a plain file in your own systems.
Licensing is per organization, with team and site options. Contact [email protected] for licensing.
Coming soon.
BryNaxa CMC Reconciler is in preparation. To talk about access, licensing, or an evaluation for your team, get in touch and we’ll set you up.