Life Sciences: Pharma Regulatory Submission Review with Claude Code: Artifact Delivery
A production playbook for pharma regulatory submission review in life sciences operations using Claude Code: artifact delivery, 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
Require Claude Code to write customer-visible files under /skill/output/artifacts, validate filenames and sizes, then return signed artifact metadata in argo.result.v1.
Tradeoffs and failure modes
Artifact policy constrains file output, but customers receive files that are durable, typed, and safe to download. 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.
Artifact manifest
artifacts:
- pharma-regulatory-submission-review-summary.md
- pharma-regulatory-submission-review-evidence.csv
- pharma-regulatory-submission-review-review.json
signed_urls: true
retention: org_policy
Run this on Argo