Specialist Consulting Regulatory Intelligence, Analytical Development and Commercial Execution
Regulatory Precision | Scientific Rigour | Strategic Commercial Partnership
Blue Ocean Strategy
Blue Ocean Strategy is ElevenGene Labs’ strategic positioning service. The programme identifies uncontested market space: segments not yet using molecular diagnostics for a given pathogen, needs that existing products leave unmet, and value combinations no current competitor offers.
Go-to-Brazil Program
The Go-to-Brazil Program is ElevenGene Labs’ market entry service. Its purpose is to map — with technical precision and regulatory depth — every requirement, gap and opportunity an in vitro diagnostics company needs to understand before, or immediately after, deciding to enter the Brazilian market.
Scientific Readiness
Scientific Readiness is ElevenGene Labs’ technical and scientific preparation service. It generates, organises and documents the analytical and clinical performance data an in vitro diagnostic product needs for ANVISA registration — robust enough to withstand the regulator’s technical scrutiny and, at the same time, strong enough to carry the commercial argument in the Brazilian market.
Diagnostic Launch Premium
Diagnostic Launch Premium is ElevenGene Labs’ most comprehensive service — the only one that takes a product from zero to the Brazilian market end to end, covering regulatory structuring, scientific validation, ANVISA dossier submission, commercial set-up and post-launch support under a single contract.
Brazil Access Platform
Brazil Access Platform is ElevenGene Labs’ ongoing local presence service. It solves a structural problem every international company faces in Brazilian in vitro diagnostics: how to maintain a qualified local presence — regulatory, technical and commercial — without opening a subsidiary, without hiring a permanent team, and without losing sight of what happens to the product in the market.
Tech Commercialization
Tech Commercialization is ElevenGene Labs’ commercial structuring and acceleration service. It addresses one specific problem: a molecular diagnostic product registered in Brazil whose sales sit far below its potential — or one just registered that needs a professional commercial structure from day one.
Scientific Due Diligence
Scientific Due Diligence is ElevenGene Labs’ independent technical assessment service. Working from verifiable scientific and regulatory evidence, it answers the question every investor and strategic buyer must settle before committing capital to an in vitro diagnostics company or product: is the technology actually good?
Method Dev Sprint
Method Dev Sprint is ElevenGene Labs’ service for developing, optimising and transferring analytical methods. It is the most technical, bench-focused package in the portfolio — solving a specific analytical performance problem on a short timeline with concrete deliverables: a validated protocol, a documented SOP and a technical report ready for audit.
Healthcare & Industrial Setup
Healthcare & Industrial Setup is ElevenGene Labs’ technical and regulatory service for anyone building, refurbishing or bringing into compliance a clinic, laboratory, hospital or medical device plant in Brazil. We are neither architects nor builders: we define what the project must contain to be approved, coordinate the licensed professionals and deliver the documentation ready for licensing — before the concrete sets over a non-conformity.