Pure Monograph — Platform

Build Your PureMonograph

Generate a complete pharmaceutical monograph for a novel molecule from scratch — QTPP, mechanism, formulation, stability, regulatory, IP, risk register. For re-engineering an existing molecule, use Reformulation.

Inspired by Rosie — AI-designed personalized neoantigen cancer vaccine for a dog

Scientific dimensions

NOVEL DESIGN

REDESIGN / CONVERT

IDEA INTAKEPlain English · AI asks clarifying questions

Describe your idea

Disease / Indication

Desired Route

Primary Goal

Program type

Upload Reference Data (optional) PDF, DOCX, CSV, FASTA, VCFTumor sequencing · Formulation data · Patent

Patient / Population Context

Hard constraints

Neoantigens / Mutations (optional — drives Target & Mechanism + Component Design grounding)

Format: GENE MUTATION, comma-separated. Each mutation must cite either a real MHC-I binding score or 'no validated source located'.

Locked scientific identity ☆

Pin INN, CID, salt, form, RLD vs RS, and pathway. A regenerate cannot silently flip them. Pathway is user-chosen — never defaulted to 505(b)(2). A field the intake marks DATA GAP is disabled and cleared; it cannot be pinned.

INN

PubChem CID

Salt

Dosage form

Strength

Pathway

Listed drug / RLD

RLD NDA

Reference standard (RS)

CEO / LEARNING MODE — Add plain-English explanations alongside technical sections

10 dimensions · CTD-ready · Uses credits (extra cost)

A — TARGET & DISEASE BIOLOGY

B — 10-AREA SCIENTIFIC ANALYSIS

C — CLARIFICATION QUESTIONS

Answer to unlock full monograph generation.

E — PURE MONOGRAPH

Trial Autopsy v2

Search literature and registries, pick a study, run a 6-lens autopsy, annotate findings.

Diagnostic lenses

RAG-grounded across 19 sources · single Grok-4 call · annotation feeds back into the dataset

1 · SEARCH

Intervention

Condition

User focus (optional)

Fans out across 19 RAG sources (~3-8s)

Trial Counterfactual

Premium biostat + regulatory consultation. Project HR and success probability against a 20–50 trial historical cohort, then apply ranked design changes with quantified probability lift — one click to regenerate.

20–50

Historical trial peers

World-class design review · dissent on every call · one-click apply & regenerate

1 · PLANNED TRIAL DESIGN

Intervention class

Indication

Phase

Sample size N

Primary endpoint

Control arm

Biomarker strategy

Additional design notes

User question (optional)

Deep CT.gov cohort (20–50 peers) + PubMed/FDA · dissent-calibrated · ~60–90s

Competitive Threat Intelligence

Full competitive brief — patent landscape, differentiation gaps, approval timeline, commercial threat score, strategic response playbook.

Strategic dimensions

Citeline charges $50K–$80K per report

COMPETITIVE TARGET

Competitor Drug

Sponsor

Target / Mechanism

Indication(s)

Stage

Your program

What concerns you

Patent · clinical · commercial · strategic response

COMPETITIVE LANDSCAPE

THREAT ASSESSMENT

STRATEGIC PLAYBOOK

Reformulation Lab

Re-engineer existing molecules. Take a molecule you already know and design one new aspect: dosage form (tablet → patch), strength (5mg → 10mg), release profile (IR → ER), or route (oral → injectable). For brand-new molecules, use Build Monograph.

Pipeline stages

Senior med-chem consultant: $500/hr × 1 week = $20K+

DESIGN INPUT

Target

Indication

Route

Current Form / Strength

Goal

Hard Constraints

CLIENT DATA + TRIAL HISTORYOptional — AI weights heavily

Upload Own Data CSV, Excel, PDF, DOCXAssay results · PK data · Formulation screens

Trial History

Prior attempt notes

5 stages · ~30 seconds · real AI calls

A — DISEASE INTELLIGENCE

B — DATABASE SWEEP

C — CLIENT CONTEXT

D — INTERROGATION

Answer all questions to continue.

E — DESIGN OUTPUT

TERMS & CONDITIONS

LAST UPDATED 2026-04-16

1. Service

Pure Monograph is an AI-assisted research tool that generates draft pharmaceutical regulatory, CMC, and design documentation for professional users.

2. No regulatory or medical advice

Outputs are experimental. You must independently verify every claim, specification, citation, and regulatory reference before clinical, manufacturing, or submission use. We make no warranty of fitness for any regulated purpose.

3. Your content

You retain ownership of documents you upload. You grant us a limited, non-exclusive licence to process them solely to produce your outputs. We do not train public models on your private uploads.

4. Acceptable use

Do not use the service to generate content for unauthorised clinical trials, to evade regulatory review, to infringe third-party IP, or in violation of applicable export controls.

5. Subscriptions & credits

Paid plans renew monthly or annually at the price shown at purchase. Per-credit purchases are non-refundable once consumed. Subscriptions may be cancelled in Settings; access continues until the end of the paid period.

6. Liability

To the maximum extent permitted by law, aggregate liability is capped at the fees you paid in the preceding 12 months. We are not liable for indirect, consequential, regulatory, or clinical-outcome damages.

7. Governing law

These Terms are governed by the laws of British Columbia, Canada. Disputes will be resolved in the courts of Vancouver, BC.

8. Contact

Questions: info@puremonograph.ai.

LAST UPDATED 2026-04-16

1. What we collect

Account data (name, email, plan), authentication metadata, usage logs (queries, credits consumed), and documents you upload for analysis.

2. How we use it

To run the service, meter usage, deliver outputs you request, send transactional 2FA codes, and improve reliability. We do not sell personal data.

3. Processors

We share the minimum necessary data with: Anthropic and xAI (model inference), Stripe (payments), Brevo (transactional email), Railway and Cloudflare (hosting and edge network). Each is contractually bound to confidentiality and data-protection terms.

4. Uploaded documents

Private uploads are processed to produce your output and retained only for your session context. They are not used to train third-party public models.

5. Retention

Account records are retained while your account is active and for up to 24 months after closure for audit, billing, and fraud-prevention purposes. You may request earlier deletion by email.

6. Your rights

GDPR/UK-GDPR/CCPA residents may request access, correction, deletion, or portability of their data by emailing privacy@puremonograph.ai.

7. Security

TLS in transit, encrypted storage at rest with the hosting provider, scoped API keys, and bcrypt password hashing. No system is perfectly secure — we will notify affected users promptly in the event of a material breach.

8. Contact

Privacy questions: privacy@puremonograph.ai. Controller: Pure Monograph, Vancouver, BC.

Pharmaceutical Intelligence

Market analysis, pipeline intelligence, competitive landscapes, regulatory trends, patent analysis, and deal flow. Select a focus and enter your topic.

Focus areas

INTELLIGENCE QUERY

Focus

Topic / Drug / Disease Area

Specific questions or angles (optional)

2,000–4,000 word analyst-grade brief

Build Your PureMonograph

Trial Autopsy v2

Trial Counterfactual

Competitive Threat Intelligence

Reformulation Lab

1. Service

2. No regulatory or medical advice

3. Your content

4. Acceptable use

5. Subscriptions & credits

6. Liability

7. Governing law

8. Contact

1. What we collect

2. How we use it

3. Processors

4. Uploaded documents

5. Retention

6. Your rights

7. Security

8. Contact

Pharmaceutical AI Chat

Pharmaceutical Intelligence

Plans

Projects