20th Annual WRIB Meeting

BioAgilytix is a global bioanalytical CRO supporting complex drug development programs with scientific rigor, proven regulatory expertise, and the operational scale required to deliver high-quality, compliant data, on time and with confidence.

We provide integrated bioanalytical services, including pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing, to pharmaceutical and biotechnology partners across every phase of development.

Our global laboratories deliver immunoassay, cell-based, molecular biology, and LC/MS assay development, validation, and sample testing within a unified quality framework, reducing handoffs, increasing consistency, and strengthening data integrity.

From early preclinical research through late-stage clinical trials, our teams take a customized, scientifically grounded approach—aligning methods, timelines, and compliance strategies to your program’s specific needs.

At BioAgilytix, automation isn’t just a feature.
It’s how we’re building the next generation of bioanalysis.

Today, our proven bench automation platforms and growing digital infrastructure support consistent, high-quality execution across our global labs.

We’re investing in connected systems and modern workflows that strengthen data integrity, traceability, and compliance — from sample receipt to final report.

Every step is documented.
Every data point is captured.
Every result is supported by evidence.

With millions of validated tests delivered each year, we combine operational scale with a clear roadmap for expanded automation.

And as we continue to invest, human oversight remains central — ensuring regulatory confidence at every stage.

Built to grow with your program — every step of the way.

We partner with biopharmaceutical sponsors to design bioanalytical strategies that align with global regulatory requirements, including GMP, GLP, GCP, CLIA, and IDE/IVDR standards.
With millions of validated assays delivered annually and decades of regulatory engagement, our teams understand what it takes to support clinical development, regulatory submissions, audits, and long-term program success.

Our role extends beyond testing. We serve as a scientific, technical, and operational partner, helping you navigate the complexity of drug development with clarity, consistency, and confidence.