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The Trusted Partner for
Bioanalytical Science and Services
BioAgilytix is the partner trusted most by leading biopharma organizations for our unrivaled track record, regulatory expertise and industry leadership at every stage of the drug development process.
With more than 30 years of experience, we excel in the most demanding areas of bioanalysis where extensive, expert-level scientific skill is required, and service excellence is expected.
Capabilities
Streamlined processes for successful method transfers
Look to BioAgilytix for proven method transfer and data integrity practices that control quality and help
ensure reproducible assay performance during drug development.
Customized method development and validation for your bioanalytical needs
Work with BioAgilytix to create custom assays tailored to your bioanalytical considerations and relevant regulatory requirements. We provide de novo assay development, partial validations, cross-matrix validations, GxP-compliant validations, or any combination of these required to meet your bioanalytical needs in a fit-for-purpose manner.
On-time, accurate, and high-quality sample analysis results during preclinical and clinical testing
Place your trust in BioAgilytix with our proven track record of delivering quality data that can withstand
regulatory scrutiny in a timely fashion. We understand that each sample is highly valuable and nothing is
as important as on-time, accurate, and high-quality sample analysis results during preclinical and clinical testing.
Customized specimen collection kits for clinical trials
Take advantage of BioAgilytix’s end-to-end support for specimen collection, including lab manuals, the
specimen collection kits themselves, logistics, and shipment tracking to destinations across the globe.
We assemble and distribute protocol-specific kits for all types of clinical trials, including single-site,
multi-site, and Phase I-IV.
Expedient analysis, accurate results, and customized reporting to fit turnaround times
Partner with BioAgilytix as your key service provider for specialized biomedical diagnostic testing
services for infectious diseases, diagnostic immunology, vitamin testing, parasite-borne infection testing,
and Laboratory Developed Tests (LDTs).
Faster timelines and reduced costs for regulated or nonregulated sample analysis
Utilize one of BioAgilytix’s off-the-shelf assays to expedite your bioanalytical project. Creating and
validating de novo assays for phase-appropriate use takes a significant amount of time. Having off-the-
shelf assays in place and ready to use for regulated or nonregulated sample analysis directly translates
into faster timelines and reduced costs, two critical aspects of designing successful preclinical and/or
clinical studies.
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Our Approach
Scientist to scientist. Sharing knowledge. Minimizing risk.
We take a uniquely consultative approach to every project. Leveraging the industry’s most complete set of capabilities and expert resources, our scientists working with your scientists to proactively anticipate assay challenges and keep you on track. Our expertise, regulatory track record, focus on quality, and continuity of scientific oversight help avoid costly delays, ensuring your therapeutic advancements reach the market sooner.
By the Numbers
Size and scale to meet demands, around the world
Scientific Insights
Our Customers Are Our Biggest Advocates
We’re proud to be regarded as a valued partner to our clients – including some of the top global pharmaceutical and biotech companies, rising biotechs, and innovative leaders in industries like agricultural biotechnology.
Having seen the result of our work firsthand, our customers are the best source of knowledge on what it’s like when you partner with BioAgilytix.