Documentation

Using Regiome

Regiome brings the authoritative public record on drugs and devices into your AI assistant. Ask questions in plain language and get answers grounded in official sources — the FDA, ClinicalTrials.gov, PubMed, the NIH, and the National Library of Medicine — with the source behind every answer. It is built for pharma and medtech teams across regulatory affairs, competitive intelligence, and R&D.

Getting started

1. In your AI assistant, add a new connector and point it at https://mcp.regiome.io.
2. The first time you connect, you will sign in or create a free Regiome account.
3. New accounts include a free trial — no credit card required.
4. Start asking. Regiome retrieves the relevant records and your assistant answers, with sources you can verify.

What you can ask about

• Drugs. FDA approvals, labeling and warnings, recalls and safety alerts, adverse-event reports, and generic, biosimilar, patent, and exclusivity information.
• Medical devices. FDA clearances and approvals, recalls, and adverse-event reports.
• Clinical trials. Find and track studies by drug, indication, sponsor, phase, and status.
• Biomedical literature. Search and summarize the published research record.
• Research funding. Explore federally funded projects and the institutions behind them.
• Terminology and reference. Look up standard medical, drug, and coding terminologies.

Example questions

• “What changed in the latest FDA label for [drug], and have there been any recalls or safety alerts in the past two years?”
• “List [company]’s recent device clearances for [device category], and summarize any related adverse-event reports or recalls.”
• “Map the clinical-trial landscape for [drug class] in [indication] — active studies, sponsors, and phases — plus the most relevant recent reviews.”
• “Build a regulatory profile for [drug]: approval history, patent and exclusivity timelines, and the generic and biosimilar picture.”

Plans and usage

Every account starts on a free trial with no credit card. For ongoing or higher-volume work, paid plans are available. You can check your remaining usage at any time by asking your assistant about your Regiome account.

What Regiome does and does not do

• It retrieves and reads public records only — it never submits reports, changes records, or acts on your behalf.
• It does not provide medical advice, diagnosis, or treatment recommendations.
• It does not access electronic health records or any private patient data.
• Adverse-event and product-problem reports are signals, not proof of causation.

Support

For questions, source-coverage requests, or account help, contact [email protected] or visit the support page.