Assay Manufacturing Services
Scalable, Compliant, and Customizable Manufacturing for Rapid Diagnostic Assays
From Prototype to Production
Gila Bioscience provides assay manufacturing services designed to take your rapid diagnostic assay from prototype to production seamlessly, reliably, and in full compliance with regulatory standards.
With decades of experience across lateral flow, ELISA, flow-through, and microfluidic platforms, our team understands what it takes to scale your assay without compromising on quality, consistency, or performance.
Whether you’re preparing for clinical trials, market launch, or regulatory submission, we deliver the contract manufacturing expertise to help you get there faster.
Our Assay Manufacturing Capabilities
Manufacturing aligned with FDA 21 CFR 820 and ISO 13485 standards to ensure regulatory compliance and traceability.
From pilot-scale validation to large-volume production, we match your timeline and throughput needs.
We support upstream formulation, striping, cutting, kitting, and downstream QC testing – all under one roof.
Detailed documentation, test reports, and design history files provided for each batch.
Robust QC testing throughout manufacturing, including in-process monitoring, lot-to-lot reproducibility, and functional assay performance checks.
What Sets Us Apart
Rapid Turnaround
Flexible timelines and efficient batch scheduling to meet product launch deadlines.
Regulatory-Ready
All manufacturing follows strict QMS standards with documentation aligned for FDA, USDA, or IVDR submissions.
Seamless Tech Transfer
We’re also your development team so scaling into manufacturing is frictionless and efficient.
Client-Owned IP & Documentation
Full transparency, including client-owned batch records and design files.
From Diagnostic Design to Commercial Deployment
As your manufacturing partner, Gila doesn’t just make tests, we build trusted, scalable systems that ensure your diagnostic product performs consistently in the field, in the lab, and in the market.
Human
Veterinary
Agriculture
Pharma
Environmental
Food Safety
Biodefense
Let Us Help You Bring Your Product to Life
With speed, precision, and confidence.
(833) 710-0912
info@gilabioscience.com