Diagnostic Launch Premium
From the ANVISA dossier to the first sale — without changing counterpart halfway through.
What Diagnostic Launch Premium is
Diagnostic Launch Premium is the only service that takes a product from zero to market under a single contract, with one integrated team accountable for the final outcome. ANVISA dossier structured. Validation executed. Distributor qualified. Technical material in Portuguese. KOLs formalised. First sales monitored. You focus on the product — we handle the entry.
Communication
You have hired regulatory, then validation, then commercial — from different suppliers who never talk to each other.
Delays
You reached registration and the distributor was not ready. The first sales took another 12 months.
Coordination
You want to enter Brazil but have no internal structure to run every front at once.
Speed
You know every month of delay is revenue that never arrives — and a competitor consolidating its position.
Do any of these sound familiar?
“Every month of delay is not just lost revenue. It is your competitor cultivating the first opinion leaders, training the distributor and becoming the reference in a segment that should have been yours.“
What We Do
| ✓ Regulatory module: diagnostic, dossier structuring and ANVISA submission ✓ Scientific module: validation protocol, assay execution and reports ✓ Commercial module: distributor qualification and contracting, technical and sales training ✓ Complete technical material developed in Portuguese (slide deck, FAQ, product sheet) ✓ Identification and formalisation of KOLs in the target segment ✓ Monitoring of the ANVISA review and response to formal deficiency letters ✓ Six months of post-registration support on the first sales |
What you receive
| ✓ Complete ANVISA dossier, submitted ✓ Analytical and Clinical Validation Reports with technical signature ✓ Distribution agreement negotiated and signed ✓ Full technical material kit in Portuguese ✓ KOLs formalised with letters of agreement ✓ Monthly progress report throughout the engagement ✓ First-sales report with commercial performance analysis |
Registering the product wins the regulatory battle. Launching the product wins the market war. Most companies celebrate the registration — and lose the war.
