Pioneering Innovation in Point-of-Care Diagnostics
From concept to commercial launch, Gila Bioscience delivers scalable, regulatory-ready solutions for point-of-care testing.
Your Full-Service CDMO for Custom Assay Development
At Gila Bioscience, we help diagnostic companies and government partners bring innovative tests to life fast. As a Contract Development and Manufacturing Organization (CDMO), we specialize in custom assay development, regulatory strategy, and GMP-compliant production across clinical, veterinary, environmental, pharma, and biodefense markets.
Whether you’re building a lateral flow assay, ELISA, or microfluidic platform, our team delivers science-driven, real-world solutions.
Services
Assay Development
End-to-end custom assay development, from feasibility through optimization
Assay Manufacturing
Scalable production aligned with FDA QSR and ISO 13485
Custom Reagents
Proprietary conjugates, nanoparticles, and bioconjugation services
Sample Collection
Device and cassette design tailored for usability and matrix compatibility
Regulatory Consulting
Expert support for FDA, USDA, IVDR, and global diagnostic submissions
Application Areas
Each industry presents unique diagnostic challenges. Gila builds custom assays and integrated testing systems that work where it matters most.
Human
Veterinary
Agriculture
Pharma
Environmental
Food Safety
Biodefense
We Do Not Just Develop Assays
We build trust, speed, and scalability into every step.
45+ Years of Combined IVD Expertise
Track Record of FDA- and AOAC-Approved Assays
Trusted by BARDA, USDA, DTRA & Leading Diagnostics Firms
Rapid Turnaround, Transparent Process, and Client-Owned IP
Ready to Start Your Project?
Let’s build something that works in the real world – accurate, fast, and ready to scale.
(833) 710-0912
info@gilabioscience.com