Pure Monograph is the first AI platform that goes end-to-end: from your molecule idea to a complete, cited, regulator-ready CTD Module 3 dossier or tech-transfer package. Built by pharmaceutical scientists, for pharmaceutical scientists.
Sources: FDA, Health Canada, EMA, ICH, USP, PubMed · 57 verified
Pure Monograph doesn't return search hits — it authors the actual documents you submit, cited and formatted to current ICH, FDA, EMA, and Health Canada guidance.
Describe a disease, target, or therapeutic goal. Pure Monograph synthesises biology, precedent molecules, PK, formulation route, and failure-mode evidence — then writes a complete, citation-backed design brief.
Unique worldwideGive a molecule name (INN, USAN, CAS, brand). The CTD Assistant instantly generates 3.2.S + 3.2.P with numeric specs, HPLC method card, dissolution, forced-degradation, ICH Q2(R2) validation tables, and stability protocol.
ICH M4Q(R2) 2025Full site-transfer package: QTPP, CPP/CQA matrix, ICH Q5E comparability protocol, process description, analytical method transfer per USP <1224>, FMEA risk register, Gantt timeline, regulatory filing strategy.
$50K consulting → minutesDesign new formulations, optimise existing ones, troubleshoot OOS or dissolution failures. QbD approach with TPP, excipient selection, CQAs, CPPs, and stability prediction. SUPAC-aware regulatory impact.
QbD co-pilotFeed any failed Phase I–III trial. Pure Monograph diagnoses the failure mode across six dimensions (patient selection, endpoint, scaffold liability, dose strategy, biomarker, competitive timing) and writes the redesign brief.
$150K IQVIA reportPatent landscape, FTO analysis, exclusivity timelines, Paragraph IV intelligence, biosimilar pathway assessment — USPTO, EPO, CIPO. Approval-probability scoring and commercial pipeline mapping.
Three patent officesUpload your own CTDs, batch records, validation reports, and internal SOPs. The AI merges your private data with public sources and cites both — with a 21 CFR Part 11 / EU Annex 11 audit trail.
AES-256 encryptedEvery generated output can be exported as a polished Word dossier or PDF — branded cover, revision history, auto-extracted executive summary, bordered tables, footer, and signature block. Ready for a partner meeting.
One-clickUSD revenue forecasts, approval probability scoring, competitive pipeline analysis, expedited-programme eligibility, and per-jurisdiction filing route (FDA 505(b)/EMA/HC) with calibrated probability ranges.
Live dataDescribe the disease, the target, or even a clinical failure you want to fix. Pure Monograph queries live biology, PK, formulation, and regulatory databases; runs a calibrated interrogation over what's unknown; then writes a complete, submission-ready design monograph with a QTPP table, ICH Q9 FMEA risk register, realistic confidence intervals, and only 2025–2026 citations.
Three steps. Minutes, not months. Every output cites its sources.
A molecule name, a disease target, a failed trial, an analytical method issue, or a draft formulation. Pure Monograph classifies the query and activates the right module.
Live queries to FDA, Health Canada, EMA, ClinicalTrials.gov, PubMed, ChEMBL, Orange Book, USP, plus your private uploads. Every claim citation-anchored, nothing hallucinated.
Word (cover, revision history, bordered tables, signature block, footer) or PDF. Includes full source list, audit ID, and Part-11-aligned disclaimer. Ready for internal review.
A single CTD dossier used to cost $50,000 and six months. Pure Monograph generates it in minutes. No contracts. Cancel anytime.
Join pharmaceutical scientists using Pure Monograph to cut regulatory document time from months to minutes.
Start free today →