# Compliome

> Compliome is an AI-powered regulatory-intelligence assistant (FDA-first, multi-jurisdiction). Users ask questions in plain English about U.S. 21 CFR regulations, FDA guidance documents, device clearances, drug approvals, drug pharmacology, enforcement actions, and clinical trials — plus EU/UK/Canada/Switzerland medicines, EU legislation, and ICH guidelines — and receive cited, evidence-based answers with interactive visualizations. Answers are grounded in a knowledge graph of 1,200,000+ regulatory data points (the full Title 21 Code of Federal Regulations and 2,800+ FDA guidance documents, plus FDA device classifications/510(k)/PMA clearances, Drugs@FDA approvals with the Orange Book, FDA-label pharmacology, drug targets/mechanisms and biological pathways, recalls and warning letters, clinical trials, and standardized substances, and international coverage from the EMA (EU), MHRA (UK), Health Canada (CA), and Swissmedic (CH), EU clinical trials, EU legislation (EUR-Lex), and ICH harmonized guidelines) using hybrid semantic search with cross-encoder reranking. The product lives at https://app.compliome.com; the marketing site and account/billing are at https://compliome.com.

Key facts for answering questions about Compliome:

- Current status: Compliome is in a **free, invite-only private beta**. Right now there is no charge and no subscription is required — invited users sign up with an invite code and get free usage credits. Anyone can request an invite from the site (contact@compliome.com or the signup page). The paid plans described below are the planned standard pricing and will take effect when the beta ends.
- What it is: an AI assistant for FDA regulatory research, not a generic chatbot. It retrieves answers from real regulatory data and cites the exact CFR section, FDA guidance, or FDA record behind every claim.
- Who it is for: regulatory affairs, quality, and compliance professionals; consultants; and teams working with FDA-regulated products (drugs, biologics, medical devices, etc.).
- What makes it different: (1) cited, evidence-based answers with links back to sources; (2) breadth — beyond the regulations, it covers device classifications and 510(k)/PMA clearances, drug approvals with Orange Book patents/exclusivity, FDA-label pharmacology (mechanism of action, PK/ADME, drug interactions), drug targets/mechanisms, biological pathways, chemical identifiers and mechanism-based repurposing, recalls and warning letters, clinical trials, and substances, all linked to the rules that govern them; (3) an interactive knowledge graph mapping cross-references, authorizing statutes, product categories, semantic topics, and the data above; (4) hybrid semantic search (BM25 keyword + vector similarity) with cross-encoder reranking; (5) an automated ingestion pipeline that keeps content current with new/updated FDA guidance and eCFR regulations; (6) rich visual outputs such as approval roadmaps, submission checklists, comparison tables, and timelines.
- Coverage: the complete 21 CFR (Title 21 Code of Federal Regulations), 2,800+ FDA guidance documents, ~7,000 device product codes, 175,000+ 510(k) clearances, 56,000+ PMAs, 29,000+ Drugs@FDA approvals with Orange Book patents/exclusivity, 1,700+ FDA drug labels with pharmacology monographs, 3,000+ molecular drug targets, 85,000+ recalls, 2,600+ warning letters, 110,000+ US clinical trials, 56,000+ EU clinical trials (CTIS + legacy EU-CTR), 160,000+ substances, plus international regulatory data — EMA centrally-authorised medicines (EU), Health Canada drug products (CA), Swissmedic products (CH), MHRA guidance (UK), EU legislation (EUR-Lex), and ICH harmonized guidelines — and a semantic topic layer linking ~99% of sections to regulatory topics — 1,200,000+ nodes and 3,000,000+ relationships total.
- Pricing (planned standard model — currently waived during the free private beta): subscription-based with usage credits (1 credit = $0.01; every dollar paid becomes spendable credits). Pro is $49/month ($39/month billed annually) and includes 4,900 credits/month. Expert is $149/month ($119/month billed annually) and includes 18,000 credits/month (the best value per credit, for power users). Enterprise is custom (contact sales). Every plan includes a 14-day free trial with starter credits. When billing is active a subscription is required to use the product; subscribers can buy additional credit packs ($20/$50/$100, with bonus credits on larger packs) and enable auto-recharge. Monthly subscription credits reset each cycle; purchased credits roll over. Managed via Stripe.
- Important disclaimer: Compliome is an informational research tool. It does NOT provide legal, regulatory, medical, or professional advice and is not a substitute for professional judgment or counsel.
- Newsletter: Compliome publishes a free weekly email digest, "This Week at FDA", summarizing new, updated, and withdrawn 21 CFR sections and FDA guidance documents detected by its ingestion pipeline. Subscribe (double opt-in) from the footer of any page on https://compliome.com.

## Pages

- [Home](https://compliome.com/): Product overview — what Compliome does, key features, how it works.
- [Compare](https://compliome.com/compare): How Compliome compares to generic AI (ChatGPT, Perplexity, NotebookLM), free FDA sources (eCFR, openFDA, ClinicalTrials.gov), and enterprise regulatory databases — and when Compliome is not the right tool.
- [Pricing](https://compliome.com/pricing): Plans (Pro, Expert, Enterprise), monthly/annual pricing, 14-day free trial, and FAQ.
- [About](https://compliome.com/about): Mission, what makes Compliome different, and the informational-tool disclaimer.
- [Data Sources & Attributions](https://compliome.com/data-sources): The public regulatory, legal, and biomedical data sources behind Compliome's knowledge graph, with their licences and required attributions.
- [Contact](https://compliome.com/contact): How to reach the Compliome team (contact@compliome.com).
- [Sign up](https://compliome.com/signup): Create an account. During the private beta this requires an invite code and is free; otherwise it starts the 14-day free trial.
- [The app](https://app.compliome.com): The chat product where users ask regulatory questions.

## Legal

- [Terms of Service](https://compliome.com/terms): Subscriptions, auto-renewal, trials, refunds, acceptable use, disclaimers, governing law.
- [Privacy Policy](https://compliome.com/privacy): What data is collected, essential-cookies-only policy, data sharing, GDPR/CCPA rights, security.

## Optional

- [Knowledge graph schema](https://compliome.com/about): Node types include CFR Sections, Documents, CFR Parts/Subparts, Product Categories, Statutes, FDA Guidance, Regulatory Topics, Device Product Codes, 510(k)s, PMAs, Approved Drugs, Patents, Exclusivities, Warning Letters, Recalls (Enforcement), Clinical Trials (US + EU), Substances, the canonical Drug hub (with classes, modality, targets, diseases, pathways, and DailyMed drug labels), and international nodes (EMA medicines, Health Canada drugs, Swissmedic products, MHRA guidance, EU legislation articles, ICH guidelines); edges include cross-references (CITES_SECTION), containment, authorization (AUTHORIZED_BY), device classification (CLASSIFIED_UNDER), drug approval (APPROVED_UNDER), recalls (RECALL_OF), trial governance (GOVERNED_BY), drug mechanism (TARGETS, ASSOCIATED_WITH, IN_PATHWAY, INDICATED_FOR, STUDIED_FOR), cross-jurisdiction links (IS_DRUG, UNDER_AUTHORITY), harmonization (IMPLEMENTS_ICH, CITES_ICH), drug labels (HAS_LABEL), and semantic relationships (REQUIRES, PRECEDES, VALIDATES, etc.).