Private AI for regulatory-affairs teams.

Find the evidence gap in a specialist review

Extract supplied facts, detect incomplete fields and compare evidence against specialist-maintained checks.

Inputs: Authorised submissions, safety-case administration, policy requirements and review records.

From observation to completed task

Create reviewer tasks and track approved follow-ups with source references.

Prepare a submission-document inventory and open-question list

The supporting records include approved dossier indexes, correspondence and internal checklists.

Specialists verify current requirements and every regulatory statement.

The systems involved

Validated case or quality-system interfaces and restricted health information.

SOS AI configures the local models and tool permissions for this workflow. Actions in business software follow the authority you approve; uncertain cases and actions outside those limits go to the responsible person.

What a useful result must get right

Qualified reviewers decide causality, coverage and regulatory conclusions; no automated medical judgments.