MOLDX
Bringing a diagnostic product or clinical lab to market requires navigating a maze of regulatory frameworks. From FDA classifications and submission types to CLIA requirements and complex state-specific licensing, many organizations underestimate the scope and sequencing of approvals.
Navigating regulatory approval is complex and fragmented. Companies often struggle with unclear pathways.
Company launches are often delayed by incomplete regulatory submissions, hindering market entry.
We provide a coordinated, cross-functional approach to regulatory readiness—so you can focus on your innovation.
At Innovexia, we bring unmatched expertise across the full regulatory landscape—bridging FDA pathways, CLIA certification, state lab licensing, and lab accreditation. Our integrated approach aligns regulatory, clinical, and operational strategies to reduce risk, accelerate approvals, and ensure long-term compliance.
MOLDX
FDA
CLIA, CAP, COLA
State Certifications
