Claude for Regulatory Document Analysis

1. Go to claude.ai
2. Click Sign up and create an account with your personal or work email
3. Verify email and log in
4. You'll see the Claude chat interface

Download the document you want to analyze:

• FDA guidances: fda.gov/regulatory-information/search-fda-guidance-documents
• ICH guidelines: ich.org/page/quality-guidelines
• ISO standards: Note that ISO standards require purchase; use a company-licensed copy or the free publicly available excerpts

Save as PDF or copy the key sections as text. Start with the sections most relevant to your question.

Option A (Claude Pro, file upload):

1. Start a new conversation
2. Click the paperclip/attachment icon
3. Upload your PDF
4. Wait for Claude to process it (usually 30-60 seconds)

Option B (free tier, paste text):

1. Start a new conversation
2. Type: "I'm going to paste a regulatory document. After I do, I'll ask you specific questions about it."
3. Paste the relevant sections (not the entire document if it's very long. Start with the most relevant chapters)

Now ask the specific question you need answered:

• "What does this guidance require for stage 2 process validation (PPQ)? List the requirements."
• "How does this document define 'critical quality attribute'? Give me the exact language."
• "What are the record retention requirements in this standard?"
• "My situation is: [describe scenario]. Does this guidance say this is acceptable? What section applies?"

Build on the initial answer:

• "What are the most common misinterpretations or compliance gaps companies have with this requirement?"
• "What evidence would an auditor typically look for to verify compliance with this section?"
• "How does this requirement compare to [other standard]? Are they aligned, or do they conflict?"

Copy the key Q&A exchanges into a reference document for your team. This becomes a fast-access interpretation guide for your department.