Prove with Data. Win with Logic.
From Tech Files to Clinical Data. We transform scattered test data into irrefutable regulatory evidence to persuade global regulators.
The Challenge
Test reports don't match the Tech File. Clinical data lacks statistical power. Disconnected data leads to rejection.
The Solution
Align the vectors. We ensure testing, clinicals, and documentation all point a single, consistent conclusion: Safety & Performance.
Key Value Propositions
Evidence Synthesis
We combine bench test results with clinical data to substantiate the strongest efficacy claims.
Documentation Automation
Minimize human error by supporting complex technical file creation with automation tools.
Mock Audit
Predict and prepare for deficiencies (R-AI) with a pre-submission rehearsal at the level of a former reviewer.
The Solution Package
Core components included in this package.
Evidence Lite
Lightweight EDC system for clinical data collection.
Technical File Writing
Global standard (STED/IMDRF) technical file writing.
Smart Formatter
Automated document formatting.
Mock Audits
Audit rehearsal and gap analysis.