BryNaxa gives pharma and biotech teams the checks and statistics behind work that has to stand up to review — stability and shelf-life, eCTD submission pre-flight, and CMC data-integrity. Every result is computed from a published method, the same way every time, and installs in-house — on your company's own server, private cloud, or desktop — private, with nothing leaving your network.
What it checks
Each is a standalone Windows application you install in-house — on your company's own server, private cloud, or a desktop — and it runs fully offline. Take only the ones your work needs — licensed per application, per machine, or per site.
On-screen analysis is free, always. The filed HTML/Excel report includes 5 free exports (watermarked), after which a licence makes it clean and unlimited. The Validation Report is licensed from first use — no free run.
Free single-document checking, always. The full sequence and submission checks each include five free runs on your own package before a licence.
Load your batch data and you get the shelf life, the capability numbers, and the plots behind them. The statistics follow ICH Q1E and run the same way on every machine.
| Attribute | Assay (% label claim) |
| Batches pooled | 3 of 3 |
| Poolability (p) | 0.41 — poolable |
| Lower spec limit | 90.0% |
| Slope | −0.34 %/mo |
BryNaxa Stability supports work you are already responsible for. It does not replace your validated systems or your judgment, and it makes no regulatory or compliance determination.
Bad reference data is quiet. A misidentified cell line, a gene symbol a spreadsheet turned into a date, a VCF built against the wrong genome — none of it announces itself, and any of it can cost months. BryNaxa's R&D applications catch these before they spread.
| Sample | MCF-7 (working stock) |
| Loci compared | Amelogenin, D5S818, TH01, vWA, +5 |
| Match to reference | 9 of 9 loci |
| Column D · row 88 | SEPT2 → “2-Sep” |
| Column D · row 214 | MARCH1 → “1-Mar” |
| Column F · row 12 | 2310009E13 → 2.31E+13 |
Illustrative results. BryNaxa's R&D applications support your own review and reproducibility checks; they do not replace your judgment or make any determination on your behalf.
Every application in the suite works the same way, so once you know one you know them all.
Point the application at your file or folder. It reads it right where it is.
The calculation runs on your machine, the same way every time.
Check the result, the plots and the assumptions before anything is final.
Save the report as PDF, Excel or HTML and keep it in your own systems.
For regulated work, where your data goes and whether a result can be defended matters as much as the answer itself.
Nothing leaves your infrastructure. The software works with your files where they are and writes the report there too.
The calculations come from published methods and run the same way on every machine. You can trace the numbers and stand behind them.
Your results are plain files you keep in your own systems. No portal to log into, no subscription to reach your own data.
BryNaxa makes in-house software for regulated life sciences — the QC, CMC, regulatory and R&D work where the data is sensitive, the methods are set by guidance, and the result has to stand up to review.
Most software in this space has moved to the cloud. BryNaxa takes the other route on purpose. The software runs in-house on your company's own infrastructure — a server, a private cloud, or a desktop you control — your files never leave it, and every result comes from a published method computed the same way every time. What you get back is a report you own and can defend. That is the standard we hold across the whole suite.
Tell us which applications fit your work and we’ll set you up. Licensing is per organization, with team and site options.
Your details go straight to our team. We usually reply within one business day.
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