Submission-ready PMTA evidence — without the consultants or the million-dollar studies.
Three in-browser modules — in-silico PK, Excess Lifetime Cancer Risk and population-health impact — turn your product data into an FDA §1114.7 / eCTD-ready report in hours. Every parameter comes from real, externally-validated sources — evidence you file directly, saving the consultant fees and bespoke lab and clinical studies a submission would otherwise cost.
Filing blind is a multi-million-dollar gamble
Before committing to clinical studies, you need credible early evidence to cut trial-and-error cost.
Methodology-transparency demands
Reviewers require parameters, models and citations to be fully traceable.
Missing early-stage quantitative evidence
Before clinical trials there is no quantitative basis for assessment.
Cross-section & cross-market comparability
Multiple SKUs and markets need one unified methodology baseline.
What this changes for your submission
From a small or mid-size manufacturer's seat, three things decide whether a submission is worth filing — clarity, a credible report, and better odds at the gate.
Bilingual guidance, accurate inputs
Every field, method note and result is available in 中文 and English — so you understand exactly what the FDA expects and enter the right numbers, instead of guessing through English-only science.
A validated, all-English PMTA-ready report
The deliverable is a professional, all-English submission-format report (no Chinese in the document): cover & document control, table of contents, an assumptions register, a data-provenance & traceability table, a 21 CFR §1114 cross-reference, an author, reviewer & QA sign-off block for your own team to complete, and full appendices — drafted the way an FDA reviewer reads it.
Better odds at the gate
No tool can guarantee a Marketing Granted Order. What rigorous, computed §1114.7 evidence does is materially raise your odds of clearing FDA's acceptance & filing review — the stage most applications stumble at — so your file is taken into substantive review.
One license, many candidates
Within your access window, run multiple product variants through all three modules — compare the evidence side by side and file the strongest, at no extra cost.
Computed evidence — not just drafted text
Each tool maps to a key FDA §1114.7 evidence element and runs entirely in your browser.
ELCR — Excess Lifetime Cancer Risk
Excess Lifetime Cancer Risk from HPHC concentrations, faithful to the FDA CTP 2024-06 memo.
- Σ ELCR and % of 1R6F reference cigarette
- OEHHA / EPA IRIS / IARC corrected IUR library
- FDA 5-level concern auto-tiering
In-silico PK
In-silico PK virtual clinical trial — Monte Carlo cohort in the browser, calibrated to observed human PK (ClinicalTrials.gov NCT03379740; Yingst 2019).
- Cmax / Tmax / AUC + 5–95% prediction interval
- CYP2A6 phenotype & weight covariates
- VPC overlay on observed human PK (ClinicalTrials.gov, Yingst 2019) — no synthetic data
PHIA — Population Health Impact Assessment
Population Health Impact Assessment via a 5/6-state Markov model over a 50–75 year horizon.
- PDA, LYG and adoption-ratio outputs
- Dual tipping-point sensitivity (switch + youth)
- Scenario A vs B comparison + Monte Carlo
A submission-grade computational platform aligned with mainstream regulatory science
The methodology of all three EBSH modules aligns strictly with the ICH, NMPA, US EPA and CORESTA international regulatory-science systems. Model equations, parameter values and citations are all public and verifiable, and output maps directly to regulatory submission section structure.
Submission-grade rigor
Model equations, parameter values and citations all meet regulatory-review traceability requirements.
Built-in uncertainty quantification
Monte Carlo sampling · reproducible seeds · bootstrap 90% CI · 5–95% prediction intervals.
Review-ready diagnostics & eCTD output
VPC self-consistency checks, sensitivity / tipping-point analysis and peer-reviewed benchmark comparison — delivered as a paginated, submission-format report (print-to-PDF + HTML) with a full method statement, assumptions register and a machine-readable scenario record in the reproducibility appendix.
Why this modeled evidence is credible
FDA's broader scientific direction supports model-based evidence: the March 2026 draft NAMs guidance (for drug development) recognizes in-silico modeling, and FDA CTP has signaled openness to computational toxicology (Cecil, 2024). For tobacco PMTAs the model is fit-for-purpose supporting evidence in a weight-of-evidence file, paired with a small confirmatory study — and every report is fully traceable, with an assumptions register, data-provenance table and a 21 CFR §1114 cross-reference.
PMTA Hub online models vs. traditional research
The same PMTA evidence elements — the traditional way, versus computed in your browser. Lab inputs you already hold (e.g. HPHC results) become validated, submission-ready evidence in minutes.
| Evidence element | Traditional research | PMTA Hub online model |
|---|---|---|
| ELCR · toxicological safety | HPHC lab results → manual IUR calc + external tox review · weeks | Same HPHC lab results → Σ ELCR auto-computed (FDA CTP 2024-06) · minutes |
| In-silico PK · §910(b) | Clinical PK study run by a CRO · months · high cost | Virtual PK trial — Monte Carlo cohort, calibrated to observed PK · minutes |
| PHIA · §910(c)(4) | Epidemiology / health-economics consultant · weeks | 5/6-state Markov PHIA model · PDA / LYG · minutes |
| Cost per element | ¥¥¥ per study or consultant engagement | One fixed, transparent price |
| Turnaround | Weeks to months | Minutes · fully self-service |
| Output & data | Format varies · raw data leaves your hands (CRO / cloud) | Validated, all-English PMTA-ready report (§1114.7) · inputs never leave your browser |
Four fixed prices. Buy online in 5 minutes.
No negotiation, no sales calls. Pick a plan, pay, and your account provisions automatically.
Pay your way: Stripe (Visa/Mastercard/Amex, USD) · Alipay · WeChat Pay · RMB corporate wire.
On-demand 6% VAT e-invoice. Full refund if unused; non-refundable once a report is viewed or exported.
Fully self-service · live within 5 minutes of payment
Standard SaaS flow — no sales follow-up, no custom quotes, no contract negotiation. Clicking buy accepts the standard terms; the system provisions your account automatically after payment. Invoices on demand.
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Start the free in-browser trial, or book a 30-minute walkthrough of the three tools and the PMTA-ready report.