How do I get started with LISA?
To join LISA and take advantage of our resources and support, contact us at [email protected].
Can international companies join LISA?
Yes!
What are the benefits of joining LISA?
As a LISA member, your lab will receive: Regulatory Compliance Support: Expert guidance on meeting FDA requirements. Technical Assistance: Access to state-of-the-art reagents and protocols. Cost Savings: Shared financial and technical burden of obtaining 510(k) clearance. Collaborative Network: Membership in a community of like-minded laboratories and industry experts.
Who are the key players in LISA?
LISA’s key players and their roles include: Argonaut Manufacturing Services: Quality control testing, cGMP manufacturing, and supply chain management. Arete Biosciences: FDA communications, regulatory requirements, and clinical trials management. SeqOnce Biosciences: Assay assessment, documentation, and transfer to manufacturing. BlazedX: Lab recruitment, technical support, and consortium organization. Epstein, Becker, and Green, P.C.: CLIA and FDA counsel […]
How does LISA help my lab comply with FDA regulations?
LISA offers comprehensive support to help ensure your lab meets FDA requirements through each phase of compliance. This includes expert guidance on regulatory submissions, access to cGMP/ISO reagents, and technical support to help you maintain compliance during the transition period.
What is LISA?
LISA (Laboratory Integration Strategic Association) is a consortium designed to support CAP and COLA-accredited diagnostic laboratories in navigating the new FDA regulatory requirements for Laboratory Developed Tests (LDTs). We provide resources, expertise, and a unique crowd-funding model to drive the development and approval of new diagnostic assays.