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regulatory-drafter
Maintainer FreedomIntelligence · Last updated April 1, 2026
Draft regulatory submissions: FDA, EMA, ICH document preparation.
Original source
FreedomIntelligence/OpenClaw-Medical-Skills
https://github.com/FreedomIntelligence/OpenClaw-Medical-Skills/tree/main/skills/regulatory-drafter
- Maintainer
- FreedomIntelligence
- License
- MIT
- Last updated
- April 1, 2026
Skill Snapshot
Key Details From SKILL.md
Key Notes
- This skill assists regulatory affairs professionals by automatically generating sections of the Common Technical Document (CTD) from raw data and literature. It focuses on accuracy, traceability, and adherence to FDA/EMA guidelines.
- Drafting CTD Sections: Automatically generate Module 2.4 (Nonclinical Overview) or Module 2.5 (Clinical Overview).
- Citation Management: When you need to synthesize multiple PDFs into a coherent narrative with inline citations.
- Audit Trails: When every claim must be traceable back to a source document.
- Drafting CTD Sections: Automatically generate Module 2.4 (Nonclinical Overview) or Module 2.5 (Clinical Overview). Citation Management: When you need to synthesize multiple PDFs into a coherent narrative with inline citations. * Audit Trails: When every claim must be traceable back to a source document.
Source Doc
Excerpt From SKILL.md
Core Capabilities
- Document Synthesis: Ingests clinical study reports (CSRs) and literature to write narrative text.
- Citation Linking: Inserts hyperlinks or references to the source material.
- Style Compliance: Adheres to eCTD formatting standards.
Workflow
- Ingest Data: Point the agent to a folder of source PDFs/Data.
- Draft: Run the drafter with a specific section target (e.g., "Nonclinical Overview").
- Review: The agent outputs a Markdown/Word draft with annotations.
Example Usage
User: "Draft the Nonclinical Overview based on the toxicology reports in ./data/tox."
Agent Action:
Use cases
- **Drafting CTD Sections**: Automatically generate Module 2.4 (Nonclinical Overview) or Module 2.5 (Clinical Overview).
- **Citation Management**: When you need to synthesi.
Not for
- Do not rely on this catalog entry alone for installation or maintenance details.
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