regulatory-submissions SKILL.md skillA
regulatory-submissions from tinh2/skills-hub-registry is an agent skill: a SKILL.md folder an AI agent loads when a task calls for it.
mdr add tinh2/skills-hub-registry/regulatory-submissions@v2.0.1Pins v2.0.1 in mdr.lock. Pin the fingerprint instead.
- Audit grade
- A, 17 of 17 checks passed
- Kind
- SKILL.md skill
- Repository
- tinh2/skills-hub-registry
- Path
analysis/regulatory-submissions/SKILL.md- Versions recorded
- 4
- Latest version
- v2.0.1, committed Sep 2, 2026
- First version recorded
- Mar 1, 2026
- Size
- 12,405 bytes
- Repository stars
- 22
- License
- none declared
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.
Collected from public GitHub. Every version is saved exactly as it was and never changes. Install it at an exact version with the mdr tool, and every file is checked before it reaches your agent. The main file is checked against the SHA-256 fingerprint recorded here, and the others against the fingerprints GitHub keeps for its source commit. The automatic checks below grade the latest version, and the same checks always give the same file the same grade.
What the file says
You are an autonomous regulatory submission analyst. Do NOT ask the user questions. Analyze and act. TARGET: $ARGUMENTS If arguments are provided, use them to focus the analysis (e.g., specific submission types, regulatory agencies, or document modules). If no arguments, scan the current project for regulatory submission infrastructure, eCTD components, and document management systems. ============================================================ PHASE 1: SUBMISSION SYSTEM DISCOVERY ============================================================ Step 1.1 -- Technology Stack Detection Identify the regulatory submission platform: - XML schemas / DTDs referencing eCTD -> eCTD backbone structure - PDF files with bookmarks and hyperlinks -> Formatted submission documents - `*.stf` / submission.xml -> eCTD sequence metadata - XSLT transforms -> Document rendering and validation - Database schemas with submission/document tables -> Document management - Integration configs for ESG (Electronic Submissions Gateway) -> FDA submission - CESP/eSubmission Gateway configs -> EMA submission - Vendor tools: Veeva Vault RIM, IQVIA RIM, Lorenz docuBridge, Extedo eCTDmanager …
Read the whole file at its exact version.
How to install
mdr add tinh2/skills-hub-registry/regulatory-submissions@sha256:a4ea72b17f044f44The line at the top of this page pins the label v2.0.1, which is what most people want. This one pins the sha256 fingerprint of the contents instead, so it survives a label being moved. Either way the exact version is written to mdr.lock, and mdr install downloads and checks those contents again, so it installs them exactly or stops with an error.
[](https://markdownregistry.com/a/art_lbdudssijgc7yiuw)
4 badge image fetches in 30 days. What the badge shows.
Versions
The registry has recorded 4 versions of this file, between Mar 1, 2026 and Sep 2, 2026, about one every 62 days.
| version | committed | commit | size | audit | |
|---|---|---|---|---|---|
| v2.0.1 latest | 2026-09-02 | a5244eb | 12,405 B | A | view · diff |
| v2.0.0 | 2026-03-18 | 851800b | 12,634 B | A | view · diff |
| v1.0.0 | 2026-03-13 | 0aafe73 | 10,877 B | A | view · diff |
| v1.0.0 | 2026-03-01 | 38b2b87 | 10,553 B | A | view |
Audit of the latest version
- pass: Frontmatter block present
- pass: Frontmatter declares a name
- pass: Frontmatter declares a description
- pass: Size between 200 bytes and 200 KB (12405 bytes)
- pass: No zero-width or bidi control characters
- pass: No instruction hidden inside an HTML comment
- pass: No link to an exfiltration or paste host
- pass: No credential-shaped string
- pass: No instruction to send local credentials anywhere
- pass: No text hidden with inline styles
- pass: No prompt-injection phrasing
- pass: No curl or wget piped into a shell
- pass: No recursive delete of root, home or parent
- pass: No instruction to read or print local credentials
- pass: No base64 blob over 200 characters
- pass: No link to a raw IP address
- pass: No script tag
Source
tinh2/skills-hub-registry · 22 stars · license none declared · pushed 2026-10-28 · branch main
API
GET https://markdownregistry.com/api/v1/artifacts/art_lbdudssijgc7yiuw GET https://markdownregistry.com/api/v1/resolve?ref=tinh2/skills-hub-registry/regulatory-submissions GET https://markdownregistry.com/api/v1/blob/a4ea72b17f044f44f7eb4cc5dcb0bb020b929930581ada4de63c9c5b38e3ecce
Your AI assistant does the legwork. You hear about the deals worth your word. Hand yours the standing instructions at modelranch.com and it joins the network that reads files like this one.
Guides: the SKILL.md format and its required fields · what to check before you install a skill · how to pin a skill to an exact version · where to find agent skills · keeping a team on the same skills · which agent file does what.