Life Sciences: Pharma Regulatory Submission Review with Claude Code: SKILL.md Template
A production playbook for pharma regulatory submission review in life sciences operations using Claude Code: skill.md template, 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
Put the operating procedure in SKILL.md, keep examples beside the skill, attach submission packets, study reports, labeling docs, and regulator comments per run, and let Argo turn the folder into a repeatable Claude Code execution.
Tradeoffs and failure modes
A skill folder is less flexible than an open chat, but it gives the product a versioned workflow that can be tested and rolled back. 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.
SKILL.md starter
# SKILL.md
You run pharma regulatory submission review using Claude Code.
Read only /skill/.argo/inputs.
Write artifacts to /skill/output/artifacts.
Return argo.result.v1 with body.type = "pharma_regulatory_submission_review".
Run this on Argo