Scientific Readiness
Your product works. Now prove it to Brazil.
What Scientific Readiness is
Scientific Readiness is ElevenGene’s analytical and clinical validation service. We generate the performance data the ANVISA dossier requires — sensitivity, specificity, LoD, reproducibility — using Brazilian samples, certified reference materials and signed reports ready for submission. We get it right the first time.
Gap hunting
You hold CE Mark and FDA clearance — but you do not know whether the data you already have will hold up in a dossier for the Brazilian population.
New Data
You submitted the dossier and received a formal deficiency letter asking for LoD or sensitivity data with 95% CI. The response clock is already running.
Precision
You are planning the submission and you know the current data will not be enough — but not exactly what will be demanded.
Getting it right
You want to avoid the most expensive mistake in the sector: generating validation data with the wrong method and having to start over.
Do any of these sound familiar?
“A formal deficiency letter from ANVISA is not just a question — it halts the review of your registration until you respond. And most of the time, it was avoidable.“
What We Do
| ✓ Analytical Validation Protocol designed to meet RDC 830/2023 and the CLSI guidelines ✓ Sample size defined with a pre-validation 95% CI calculation — no surprises in the result ✓ Access to our partner laboratory network, with samples confirmed by a gold-standard method ✓ Assay execution: SE/SP, LoD, precision (intra- and inter-assay CV), cross-reactivity ✓ Full statistical analysis, using the Rogan-Gladen method where applicable ✓ Analytical Validation Report signed by a qualified technical officer ✓ Clinical Validation Report where the product’s classification requires one |
What you receive
| ✓ Approved Analytical Validation Protocol ✓ Analytical Validation Report — in the format ANVISA accepts ✓ Clinical Validation Report where applicable ✓ Raw data tables with full sample traceability ✓ Certificates for every reference material used ✓ Technical opinion on whether the data is fit for submission |
Free tool: Not sure which performance data ANVISA will demand for your product? The free assessment points out the gaps in about 10 minutes. Open ANVISA Readiness.
A sensitivity figure of 97% is impressive in a pitch. But if it was calculated without a 95% CI and without Brazilian samples, it is a time bomb in the dossier.
