ClaudSkills / General / legal-compliance

Regulatory Submission Summary

Q: What is a Claude Code skill and how does the Regulatory Submission Summary skill fit in?

A Claude Code skill is a SKILL.md file that lives under ~/.claude/skills/<name>/ and tells the Claude Code CLI agent how to perform a specific task (instructions, prompts, allowed tools). Skills are auto-discovered at session start. Regulatory Submission Summary is one of 67,000+ skills indexed in the open ClaudSkills catalog, classified under the General category. Learn more at https://claudskills.com/learn/what-is-skill-md/.

Category: General · Sub-category: legal-compliance · Last updated: 2026-06-06

type:review

Produces structured summaries of regulatory submission packages (FDA NDAs, 510(k)s, BLAs, ANDAs, environmental permits, rate filings) for government approval processes. Distills clinical data, manufacturing information, compliance evidence, and supporting documentation into standardized overviews for regulatory reviewers, compliance teams, and executives. Use when summarizing submission packages, preparing regulatory filing overviews, or creating executive briefings on approval applications; trigger keywords: regulatory submission, NDA summary, 510(k) summary, BLA summary, filing overview, approval application, regulatory briefing, submission package.

About this skill (catalog notes)

Regulatory Submission Summary includes a dedicated installation section. The SKILL.md runs to about 793 words, in the catalog's typical mid-range.

License: Apache-2.0
Original author: CaseMark
Indexed lastmod: 2026-06-06
Catalog position: General · legal-compliance
Indexed related skills: 10

How Regulatory Submission Summary fits the catalog

Regulatory Submission Summary sits in the General category under the legal-compliance sub-topic in the ClaudSkills catalog. There are 10 related skills indexed alongside it; comparing a few before installing usually reveals which fits your workflow best.

These notes are auto-generated from features detected in the SKILL.md file and from this catalog's structure — they aren't part of the source repository.

From the source SKILL.md

Produces a structured summary of a regulatory submission package, enabling reviewers to quickly assess purpose, scope, supporting evidence, and compliance posture.

What this skill does

Regulatory Submission Summary 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-submission-summary/ and loads when your prompt matches the skill's trigger.

When to invoke it: Use when summarizing submission packages, preparing regulatory filing overviews, or creating executive briefings on approval applications; trigger keywords: regulatory submission, NDA summary, 510(k) summary, BLA summary, filing overview, approval application, regulatory briefing, submission package.

Who uses this skill

The Regulatory Submission Summary 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 93,000+ 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-submission-summary
curl -L https://claudskills.com/skills/regulatory-submission-summary/SKILL.md \
  -o ~/.claude/skills/regulatory-submission-summary/SKILL.md

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

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

📱 Install from your phone or desktop Telegram

Open @claudskills_bot on Telegram, tap Open Desktop App, and the desktop app installs this skill for you. Or share the bot link with a colleague — they get the same one-tap install. Learn more →

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

Frequently asked questions

How do I install the Regulatory Submission Summary Claude Code skill?

Install via the ClaudSkills desktop app (one click) or copy SKILL.md from the source repository to ~/.claude/skills/regulatory-submission-summary/SKILL.md and restart Claude Code. Both flows are detailed at claudskills.com/install/.

What does the Regulatory Submission Summary skill do?

Is this skill free to install?

Yes. ClaudSkills is an open registry — every skill keeps its source repository's license, and manual install via copy is free. ClaudSkills Pro ($9/mo, $79/yr, or $149 one-time) adds one-click install via the desktop app and a multi-signal Quality Score.

When should I use the Regulatory Submission Summary skill?

Use Regulatory Submission Summary when your Claude Code task falls under the General category — specifically in the legal compliance area. Claude Code auto-discovers installed skills and invokes the right one based on the task description, so you can also ask Claude directly (e.g. "use Regulatory Submission Summary" or describe the task and let Claude pick). Browse related skills at /category/general/.

What is a Claude Code skill and how does the Regulatory Submission Summary skill fit in?

A Claude Code skill is a SKILL.md file that lives under ~/.claude/skills/<name>/ and tells the Claude Code CLI agent how to perform a specific task (instructions, prompts, allowed tools). Skills are auto-discovered at session start. Regulatory Submission Summary is one of 67,000+ skills indexed in the open ClaudSkills catalog, classified under the General category. Learn more at /learn/what-is-a-claude-skill/.

Attribution & license

Source: https://github.com/ThomasMoreAI/legal-skills-open/blob/HEAD/us/regulatory/skills/regulatory-submission-summary/SKILL.md
License: Apache-2.0
Author: CaseMark

Cite this skill

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

APA

CaseMark. (2026). Regulatory Submission Summary [Claude Code skill]. ClaudSkills. https://claudskills.com/skills/regulatory-submission-summary/

BibTeX

@misc{regulatory-submission-summary-2026,
  author    = {CaseMark},
  title     = {Regulatory Submission Summary [Claude Code skill]},
  year      = {2026},
  publisher = {ClaudSkills},
  url       = {https://claudskills.com/skills/regulatory-submission-summary/}
}

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