Question 1

How often is the guidance database updated?

Accepted Answer

FDA guidances are updated weekly via our automated pipeline. EMA data refreshes daily from the EMA Open Data portal. ICH guidelines are checked monthly. You can set up alerts to be notified when specific documents change.

Question 2

Can I search across multiple agencies at once?

Accepted Answer

Yes. By default, searches query all four agencies (FDA, EMA, ICH, Health Canada) simultaneously. You can filter to specific agencies using the sidebar checkboxes. Results are ranked by relevance regardless of source.

Question 3

What does the AI summary include?

Accepted Answer

The AI summary generates a 200-word clinical pharmacology-focused overview covering: what the guidance addresses, key regulatory recommendations, relevant PK calculations and PharmKit tools, and the document status and publication date. Summaries cost 1 AI credit and are cached — subsequent views of the same document are free.

Question 4

How does the compare feature work?

Accepted Answer

Select 2 documents using the Compare checkbox, then click "Compare Selected." The AI analyzes both documents side-by-side, highlighting key differences, similarities, and scoring regulatory divergence across 5 dimensions (methodology, thresholds, study design, data expectations, special populations). Comparisons cost 2 AI credits.

Question 5

Is this a replacement for VivPro or Cortellis?

Accepted Answer

PharmKit provides free access to the same public regulatory data that VivPro ($50-200K/yr) and Cortellis ($80-200K/yr) charge for. Our unique advantages include direct cross-links from guidance text to PK calculators, multi-agency comparison with divergence scoring, and AI-powered summaries — features neither competitor offers.

Regulatory Guidance Explorer

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