Agency meeting, authoring, and submission evidence intelligence

Build controlled regulatory packages that stay connected to the evidence.

Bayes Pharma.ai Regulatory Authoring turns product master data, agency questions, sponsor positions, CTD intent, model-informed evidence, CMC, nonclinical, clinical, safety, statistics, and labeling context into source-backed drafts, readiness dimensions, claim-to-evidence matrices, reviewer actions, and submission-ready support packages.

Regulatory hub Submission suite
Master

Lock program data

Capture sponsor, product, active substance, application, sequence, agencies, studies, sites, and commitments as the package spine.

Score

Separate readiness

Score scientific evidence, documents, traceability, technical CTD checks, review, agency fit, and final submission readiness independently.

Trace

Map claims

Connect each draft claim to source artifacts, owners, uncertainty, module location, model versions, dataset versions, and missing evidence.

Control

Govern review

Assign owners, issue status, document lifecycle states, due dates, approval status, sign-off timestamps, and audit-ready next actions.

Readiness

Regulatory authoring package

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Ready
Persistence, export, and handoff actions will appear here after the authoring inputs are ready.