AVSA, LLCCompanion Diagnostics Consulting
We guide Pharma and Diagnostic companies through the complex US FDA regulatory landscape for Companion Diagnostics — from first contact with CBER/CDER and CDRH through approval, validation, and commercial use — with a relentless focus on reducing time to market.
In the US, a CDx may be classified as Class III or Class II by the US FDA. At AVSA, LLC, we specialize in guiding Pharma and Diagnostic companies through the complex regulatory landscape of Companion Diagnostics (CDx) with the US FDA. We cover everything from feasibility testing and development to verification, validation, assay transfer, and commercial use.
Our tailored consulting services are designed to reduce time to market and make it easy for the US FDA to collaborate with you — allowing you to concentrate on innovation and deliver precision medicine to patients in a timely manner.
With regulators, Pharma & diagnostics partners. A robust regulatory strategy is crucial to your CDx device. We provide guidance on up-to-date pathways, helping you select the optimal, least burdensome approach to minimize time and cost while ensuring compliance.
Navigating the FDA submission process can be daunting. We offer end-to-end support — from preparing QMS and regulatory documents to communicating with the FDA on your behalf — with a focus on the least burdensome submission.
Ensuring the clinical and analytical validity of your CDx is key to gaining FDA approval. Our team supports verification and validation studies, optimizing them for fast-track results with minimal burden.
As software and cybersecurity become increasingly critical in CDx devices, we offer specialized support to ensure your software meets FDA's rigorous validation standards, including cybersecurity assessments.
A strong QMS is essential for CDx device compliance. We provide support across all phases of product development, ensuring alignment with FDA regulations and industry standards for a streamlined, fast-tracked pathway to market.
Maintaining compliance doesn't end at approval. We provide ongoing support to navigate post-market requirements and keep your device compliant — with an eye on streamlined processes that continue to reduce burden.
Direct experience dealing with the US FDA brings unparalleled knowledge of regulatory requirements and industry standards for Companion Diagnostics — ensuring fast and least burdensome submissions.
We have successfully guided numerous companies through the FDA submission process, securing approvals and accelerating time-to-market for CDx devices through optimized, streamlined pathways.
Expert support for analytical and clinical validation, software and cybersecurity validation, and navigating the complexities of bridging study pathways and risk determinations.
From feasibility testing to commercial use, we support all phases of your product development under a robust QMS — ensuring a fast-tracked, least burdensome pathway to market.
Every device is unique, and so is our approach. We provide customized consulting designed to meet the specific needs of your CDx device, focused on fast-tracking approval with the least regulatory burden.
Ready to navigate the regulatory landscape of Companion Diagnostic devices with confidence and speed? Contact us today to schedule a consultation and take the first step towards fast-tracked, least burdensome FDA approval.