PMTA evidence, modeled in an hour — not years.
Run virtual PK trials, excess-cancer-risk and population-health models right in your browser. Generate §1114.7-formatted supporting evidence and decide which formula to file — before you spend millions.
Filing blind is a multi-million-dollar gamble
Before committing to clinical studies, you need credible early evidence to cut trial-and-error cost.
High cost of a wrong bet
Average full PMTA submission per single SKU — spent before you know if the formula clears.
Decision cycles drag
From R&D kickoff to a marketing-granted order — too long to learn by filing.
No early quantitative data
Formula-screening stage lacks the numbers to rank candidates with confidence.
Computed evidence — not just drafted text
Each tool maps to a key FDA §1114.7 evidence element and runs entirely in your browser.
InSilico-PK
Population-PK virtual clinical trial — Monte Carlo over a 500-subject cohort in the browser.
- Cmax / Tmax / AUC + 5–95% prediction interval
- CYP2A6 phenotype & weight covariates
- VPC-style diagnostics, no fabricated data
ELCR Calculator
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
PHIA Model
Population health impact 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
An FDA-encouraged scientific pathway
FDA's 2026 New Approach Methodologies draft lists in-silico models as a scientific alternative pathway. Our tools align with the mainstream frameworks — every report ships 14–21 traceable citations.
Quantitative evidence vs. AI writing assistants
Drafting tools rephrase your narrative. EBSH computes the numbers that narrative has to defend.
| Capability | AI writing assistants | EBSH · MIRS |
|---|---|---|
| What it produces | Drafted application text | Computed PK / risk / PHIA values with CIs |
| Evidence type | Narrative only | §910(b) & §910(c)(4) modeled evidence |
| Reproducibility | Not reproducible | Seeded Monte Carlo · version-pinned params |
| Data privacy | Uploaded to a cloud LLM | Stays in your browser — we never receive it |
| Best used | Late-stage drafting | Early go/no-go formula screening |
Four fixed prices. Buy online in 5 minutes.
No negotiation, no sales calls. Pick a plan, pay, and your account provisions automatically.
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7-day full refund · on-demand 6% VAT e-invoice · cancel anytime from your dashboard.
See your formula's evidence today
Start the free in-browser trial, or book a 30-minute walkthrough of the three tools and the PMTA-ready report.