---name: regulatory-drafter description: Drafts regulatory documents (FDA, EMA) with audit trails and specific "Thinking Block" reasoning. Use for high-stakes compliance writing.

keywords:

• regulatory-drafter
• automation
• biomedical measurable_outcome: execute task with >95% success rate. ---"

Regulatory Document Drafter

This skill generates compliant drafts for regulatory submissions, emphasizing auditability and adherence to guidelines (ICH, FDA).

When to use this skill

• When asked to write sections of an IND, NDA, or CSR (Clinical Study Report).
• When responding to "Request for Information" (RFI) from health authorities.
• When the user requires "reasoning" or "thinking" to be visible (Anthropic style).

How to use it

1. Analyze Context:
   • Identify the specific regulatory document type (e.g., "Module 2.5 Clinical Overview").
   • Retrieve relevant guidelines (e.g., "FDA Draft Guidance on X").
2. Thinking Block (Internal Monologue):
   • Before writing, outline the strategy in a <thinking> block.
   • Assess potential risks or claims that require citation.
3. Drafting:
   • Use formal, objective regulatory language (e.g., "The data suggest..." instead of "We proved...").
   • Insert placeholders for data references [Link to Table 14.2.1].
4. Audit Trail:
   • Append a "Compliance Check" section listing which guidelines were consulted.