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Regulatory Submissions

Category: General  ·  Sub-category: legal-compliance  ·  Last updated:
type:audittype:integration
Audit a pharmaceutical regulatory submission system -- evaluate eCTD backbone assembly and XML validation, CTD module completeness (Modules 1-5), FDA ESG and EMA CESP gateway integration, document authoring and publishing workflows, ICH M4/M8/E3 guideline compliance, pre-submission validation rules, 21 CFR Part 11 audit trails, and post-submission lifecycle tracking. Covers IND, NDA, BLA, ANDA, MAA, and variation submissions using Veeva Vault RIM, IQVIA, Lorenz docuBridge, or custom platforms.

From the source SKILL.md

You are an autonomous regulatory submission analyst. Do NOT ask the user questions. Analyze and act.

What this skill does

Regulatory Submissions is a community-contributed Claude Code skill in the legal-compliance sub-category. It ships as a SKILL.md file that Claude Code auto-discovers under ~/.claude/skills/regulatory-submissions/ and loads when your prompt matches the skill's trigger.

Who uses this skill

The Regulatory Submissions Claude Code skill is built for Claude Code users and developers across all disciplines looking for general-purpose AI assistance. It's part of ClaudSkills (also referred to as Claude Skills or Claude Code Skills) — the open community-curated registry of 70,000+ SKILL.md files for Anthropic's Claude Code agent and the wider Claude ecosystem (Claude API, Claude Agent SDK).

How to install

Free

Manual install (2 steps)

mkdir -p ~/.claude/skills/regulatory-submissions
curl -L https://claudskills.com/skills/regulatory-submissions/SKILL.md \
  -o ~/.claude/skills/regulatory-submissions/SKILL.md

Or just download SKILL.md directly and drop it into ~/.claude/skills/regulatory-submissions/. Claude Code auto-discovers it on next session.

Skills live at ~/.claude/skills/regulatory-submissions/SKILL.md on macOS/Linux, or %USERPROFILE%\.claude\skills\regulatory-submissions\SKILL.md on Windows. See the full install guide for step-by-step instructions.

Pro

One-click install via the desktop app

The ClaudSkills desktop app installs any skill directly into ~/.claude/skills/ with one click — no terminal required. Pro starts at $9/mo or $149 lifetime.

Pro

For the full experience including quality scoring and one-click install features for each skill — upgrade to Pro.

See pricing → Download desktop app

Cite this skill

If you reference this skill in a blog post, paper, or documentation, you can cite it as:

APA
ClaudSkills. (2026). Regulatory Submissions [Claude Code skill]. ClaudSkills. https://claudskills.com/skills/regulatory-submissions/
BibTeX
@misc{regulatory-submissions-2026,
  author    = {ClaudSkills},
  title     = {Regulatory Submissions [Claude Code skill]},
  year      = {2026},
  publisher = {ClaudSkills},
  url       = {https://claudskills.com/skills/regulatory-submissions/}
}

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