Life Sciences: Pharma Regulatory Submission Review with Claude Code: Result JSON Schema
A production playbook for pharma regulatory submission review in life sciences operations using Claude Code: result json schema, run-scoped inputs, logs, typed results, and artifacts.
Audience: Life sciences regulatory teams
The problem
Life sciences regulatory teams need pharma regulatory submission review to run repeatedly against submission packets, study reports, labeling docs, and regulator comments. In life sciences operations, the pain is not one good answer; it is repeatability, auditability, exception handling, and evidence that survives handoff.
Implementation path
Define the outer result contract once, let the pharma regulatory submission review skill own body.data, and reject terminal output that does not match the expected schema.
Tradeoffs and failure modes
Schema enforcement adds upfront design work, but removes prompt parsing from the product surface. For pharma regulatory submission review, the practical test is whether a second run can be debugged, retried, and consumed by a product without reading the raw agent transcript.
Result shape
{
"schema_version": "argo.result.v1",
"summary": "pharma regulatory submission review completed",
"body": { "type": "pharma_regulatory_submission_review", "data": {}, "exceptions": [] },
"artifacts": []
}
Run this on Argo