Pharma Partnerships
Precision CDx Development for Companion Diagnostics & Therapeutic Monitoring
Collaboration to Accelerate CDx Development
Collaboration with pharmaceutical and biotech companies to accelerate Companion Diagnostics (CDx) development delivering reliable, scalable, and regulatory-aligned companion diagnostic assays to support targeted therapies. As a Contract Development and Manufacturing Organization (CDMO), we specialize in creating point-of-care and near-patient testing tools that complement clinical development and support precision medicine strategies.
Whether you’re validating a predictive biomarker, monitoring drug adherence, or preparing for regulatory submission, Gila is your partner for agile, real-world assay development across complex matrices and timelines.
End-to-End Support for CDx Development
We provide complete support for every stage of companion diagnostic development.
Biomarker & Assay Feasibility
Reagent design and optimization.
Matrix compatibility studies.
Early-stage assay prototyping.
Analytical & Clinical Validation
Sensitivity, specificity, and reproducibility evaluations.
Usability and robustness for clinical trial integration.
Stability studies and device optimization.
Regulatory Pathway Navigation
Support for FDA, EMA, and global submissions.
Alignment with 21 CFR Part 820 and ISO 13485 QMS.
Documentation for EUA, 510(k), or PMA.
Manufacturing & Scale-Up
GMP-compatible pilot and full-scale manufacturing.
Custom reagent formulation and kitting.
Batch release testing and ongoing stability programs.
Applications of CDx & Pharma Diagnostic Tools
Therapeutic Drug Monitoring (TDM)
e.g., Tenofovir adherence testing in HIV programs.
Biomarker-Guided Screening
Oncology and chronic condition support.
Pharmacovigilance
Post-market monitoring and patient compliance.
Rapid Field Testing
For low-resource or decentralized care environments.
CDx Development with Gila Bioscience
Flexible & Responsive CDMO Partnership
Agile team with experience supporting both startups and established pharma.
Point-of-Care & Lab-Ready Expertise
Diagnostics engineered for deployment in a variety of healthcare settings.
Regulatory & Quality Confidence
Track record of FDA and IVDR assay programs.
Speed to Market
Shorter development timelines through in-house prototyping and process integration.
Projects We’ve Supported
Tenofovir Monitoring Assay
Rapid test for adherence to HIV antiretrovirals in global public health initiatives.
Insulin Monitoring Research Tools
For controlled drug delivery and metabolic response tracking.
Ready to Accelerate Your CDx Program?
Whether you’re building a companion diagnostic for a targeted therapy or optimizing an existing test for global deployment, Gila Bioscience offers the scientific insight and CDMO capacity to move your CDx development forward with confidence.
(833) 710-0912
info@gilabioscience.com