Pure Monograph searches 61+ authoritative databases — FDA, EMA, Health Canada, USP, PubMed, ChEMBL — and cross-verifies every claim through dual AI engines. Get CTD-ready compliance reports, gap analyses, and regulatory submission support in minutes, not weeks.
Live openFDA integration — search 20,000+ drug products instantly. Real validation logic checks assay, dissolution, and impurity specs against USP, BP, Ph. Eur., and JP monographs with automated compliance scoring.
5 CTD Modules · 12 Quality Checkpoints — covering Module 1 through Module 5, with deep quality sub-section analysis from 3.2.P.5 Stability to 3.2.S.4 Analytical Methods. Due diligence reports, gap analyses, compliance checks, and submission packages — all with full citations and remediation steps.
Aggregating intelligence from 61+ authoritative sources
Unlike basic AI tools, Pure Monograph checks answers twice using two top AI engines and combines public data with your private data securely.
Our AI quickly finds issues in data — like unusual patterns or stability concerns — and suggests the best ways to make drugs stable and effective, saving you weeks of manual testing and literature review.
Designed to meet rules from FDA (U.S.), Health Canada, EMA (Europe), and others. Everything is trackable, auditable, and safe. Regulatory document support means compliance guidance is built-in, not bolted on.
Get advice on costs versus benefits so you spend less but get more from your projects. Our AI identifies optimization opportunities that can reduce development timelines by weeks or months.
We use special tech including privacy protection and secure records to mix public info with your private data safely. Your proprietary formulations and trade secrets stay protected at every step.
From live openFDA product lookups to 12 quality checkpoints across all 5 CTD modules, Pure Monograph gives your team a single command center for every stage of pharmaceutical due diligence.
Automated compliance checks across all 5 CTD modules with 12 quality checkpoints. Search any drug product — by preset, custom entry, or live openFDA query — and get instant gap analysis with remediation steps.
Check your product specs against USP, BP, Ph. Eur., and JP monographs simultaneously. Toggle between pharmacopeias, compare acceptance criteria, and flag discrepancies automatically.
Generate four distinct report types tailored to your workflow — Due Diligence, GAP Analysis, Compliance, and Submission — each exportable as a formatted PDF with full regulatory citations.
Powered by 61+ authoritative sources including FDA, EMA, Health Canada, USP, PubMed, ChEMBL, and DrugBank.
Search 20,000+ drug products in real-time. Pull product details, labeling, adverse events, and approval data directly from FDA's open database — no manual lookups needed.
Forecast how drugs will behave, find errors early, and increase your chances of success with predictive formulation analysis and stability modeling.
Validate against USP, BP, Ph. Eur., and JP simultaneously. Toggle between pharmacopeias, compare acceptance criteria, and identify regional compliance gaps in one view.
Auto-generate reports across all 5 CTD modules with 12 quality checkpoints — compliance checks, gap analysis, remediation steps, and timeline estimates from 3.2.P.5 Stability to 3.2.S.7 Drug Substance Stability.
Get results as real-time answers, exportable PDFs, structured data tables, or full regulatory-ready document packages. Four report types cover every workflow stage.
Every query is independently answered by two AI engines, then reconciled with confidence scoring. Contradictions are flagged, consensus is transparent — with full source attribution.
Five simple steps from question to verified, cited answer. Begin with free access, upgrade for more features.
Upload your data safely or type any pharmaceutical question in plain language.
Our engines search 61+ databases simultaneously — PubMed, FDA, USP, ChEMBL, and more.
Two independent AI engines verify every claim. Contradictions flagged, confidence scored.
See verified answers with full citations. Download PDFs, structured reports, or data exports.
Integrate into your workflow. System learns from usage to deliver better results over time.
Every query is independently processed by two leading AI systems, then cross-checked for agreement. This is how pharmaceutical-grade accuracy works.
Each AI engine independently identifies factual claims, data points, and regulatory references from its response.
Claims are compared and scored. Agreement above 85% = verified. Below 60% = contradiction flagged for manual review.
Every claim is traced back to its original source — USP monograph, FDA guidance, PubMed study — with direct links.
Early adopters are already seeing results across formulation, regulatory, and CMC workflows.
Options for everyone, from individual researchers to enterprise teams. Paid plans include a 7-day free trial.
| Feature | Free | Individual | Corporate Basic | Enterprise |
|---|---|---|---|---|
| Queries | 10/day | Unlimited | Unlimited | Unlimited |
| AI Engines | Single | Dual Verified | Dual Verified | Dual + Custom |
| Database Access | 61+ public | 61+ public | 61+ public + proprietary | All + custom |
| PDF Exports | — | ✓ | ✓ | ✓ |
| Predictive Formulation | — | ✓ | ✓ | ✓ |
| Team Seats | 1 | 1 | Up to 5 | Unlimited |
| Proprietary Archive | — | — | ✓ | ✓ |
| API Access | — | — | ✓ | ✓ |
| Expert Calls | — | — | 4 hrs/mo | Custom |
| SSO & Security | — | — | — | ✓ |
| Dedicated Manager | — | — | — | ✓ |
| SLA Guarantee | — | — | — | ✓ |
Our proprietary archive contains original CMC documentation, stability protocols, analytical validations, and batch records from our own pharmaceutical development programs — generated by our scientists, in our labs, through our regulatory process.
This is our own IP, not third-party data. Qualified Corporate Basic and Enterprise subscribers can access detailed, unredacted data under NDA for biosimilar development, regulatory strategy, or competitive analysis.
Note: Full originator CTDs from other companies are never publicly available. Our archive provides comparable data from our own parallel development programs.
Accelerated, long-term, photostability, forced degradation — complete protocols with results.
Validated HPLC, SE-HPLC, peptide mapping methods with full chromatographic data.
Manufacturing process details, equipment specs, process validation summaries.
Module 3.2.S (Drug Substance) and 3.2.P (Drug Product) reference data with container-closure information.
Packages range from Basic CMC & Stability ($7,500–$15,000) to Annual License + Updates ($30,000–$80,000/year). All require signed NDA and compliance review.
We're Pure Monograph, a helpful AI tool from Vancouver, BC, Canada. We make drug development simpler by using AI to optimize formulations, predict results, find issues, and handle transfers from research to production.
We built this platform because we lived the problem — searching across dozens of databases, manually assembling regulatory documents, re-validating analytical methods from scratch. Pure Monograph is the tool we wished existed.
Our proprietary archive isn't licensed third-party data. It's documentation from our own internal pharmaceutical development programs. That's why we can share it with confidence and why it has real value for teams working on similar compounds.
Our mission: Make every part of creating drugs easy and reliable with AI that's fair, traceable, and secure. From analyzing data to making approval papers, we turn hard tasks into simple steps.
Questions about plans, proprietary access, or enterprise partnerships? We'd love to hear from you.
📧 info@puremonograph.ai 🏢 enterprise@puremonograph.ai 💼 sales@puremonograph.aiPure Monograph Ai Ltd.
Vancouver, BC, Canada