AVSA, LLCCompanion Diagnostics Consulting
We guide Pharma and Diagnostic companies through the complex US FDA regulatory landscape for Companion Diagnostics — from early interactions with CDER, CBER (when applicable), and CDRH through clearance or approval, validation, and commercial use — with a relentless focus on reducing time to market.
Most FDA-cleared or approved companion diagnostics have been regulated as Class III devices through PMA, although certain companion diagnostics may be classified as Class II depending on their intended use and risk profile. 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 support effective communication with FDA review teams — 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 assisting clients with FDA communications — with a focus on the least burdensome submission.
Ensuring the clinical and analytical validity of your CDx is key to gaining FDA clearance or approval. Our team supports verification and validation studies, optimizing them for efficient results with minimal burden.
Software lifecycle and cybersecurity documentation aligned with applicable FDA guidance and recognized consensus standards.
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, efficient pathway to market.
Maintaining compliance doesn't end at clearance or 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.
Extensive experience working with FDA-regulated medical devices brings in-depth knowledge of regulatory requirements and industry standards for Companion Diagnostics — helping clients pursue efficient and least burdensome regulatory pathways.
We support medical device companies through FDA regulatory submissions, 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 an efficient, 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 efficient clearance or 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 efficient, least burdensome FDA clearance or approval.