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Ask anything about CMC, regulatory submissions, formulation science, or generate a full CTD package.
Ask anything about CMC, regulatory submissions, formulation science, or generate a full CTD package.
1. Acceptance. By using PureMonograph, you agree to these terms. PureMonograph is a regulatory intelligence tool — outputs are AI-generated and must be reviewed by qualified regulatory professionals before submission.
2. Data Privacy (PIPEDA/GDPR). We collect only what you provide. Documents uploaded are encrypted (AES-256), used solely for your session, and not retained beyond session expiry. No document content is used to train AI models.
3. Audit Trail. All queries are logged with SHA-256 hashes per 21 CFR Part 11 requirements. Logs are available on demand via the Audit Trail panel.
4. Electronic Signatures. Signatures generated via PureMonograph's e-sign feature use Web Crypto SHA-256 and are timestamped. They constitute valid electronic records under 21 CFR Part 11 § 11.100 when used with appropriate identity verification.
5. No Regulatory Advice. PureMonograph outputs do not constitute legal or regulatory advice. Always consult a licensed regulatory affairs professional for submissions to Health Canada, FDA, or EMA.
6. Jurisdiction. Governed by the laws of British Columbia, Canada. PIPEDA-compliant data handling. EU users: GDPR Article 6(1)(b) lawful basis.
Data We Collect: Email address, query history (hashed), and uploaded document text (encrypted). No PHI, no IP tracking beyond security purposes.
Document Uploads: AES-256 encrypted at rest. Not shared with third parties. Not used to train AI. Deleted on session expiry or manual removal. Maximum retention: 30 days.
Third Parties: Grok (xAI) for AI inference — queries sent without PII. Railway for hosting. Stripe for billing. No data sold to data brokers.
Your Rights (GDPR/PIPEDA): Access, rectification, erasure, portability. Email privacy@puremonograph.ai to exercise rights. Response within 30 days.
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Contact: Burrard Pharma Inc., Vancouver, BC, Canada. privacy@puremonograph.ai
Uploaded document becomes Layer 3 private knowledge — injected into every query for this session only.
| Phase | Overall | Oncology | CNS | Cardiovascular |
|---|---|---|---|---|
| Phase 1 | 52% | 37% | 46% | 55% |
| Phase 2 | 28% | 18% | 22% | 32% |
| Phase 3 | 57% | 51% | 49% | 62% |
| NDA/BLA Review | 85% | 82% | 78% | 87% |
| Phase 1 → Approval | 12% | 6% | 8% | 14% |
Sources: DiMasi JA et al. J Health Econ (2016); FDA CDER Annual Report (2021). These figures are injected automatically when you ask about approval probability.