- Senior Director, Clinical & Translational Sciences
Client since 2005
How BioAgilytix Supports Regulated Bioanalysis Studies
BioAgilytix is one of the largest bioanalytical LC/MS/MS service providers on the West Coast, with headquarters in San Diego, California for over 20 years. We help our clients develop novel therapeutics by supporting clinical and preclinical regulated bioanalysis studies. Since 1998, BioAgilytix has supported 290+ clients in 45 countries, completed over 8,200 projects, and developed more than 2,400 methods.
High-Quality Regulated Bioanalysis Studies for the Entire Drug Development Process
BioAgilytix specializes in bioanalytical and pharmacokinetic analysis. Our core expertise is providing our clients with industry-leading bioanalytical, drug metabolism, and pharmacokinetic analysis services throughout the drug development process, from discovery to NDA filing. Here’s why researchers choose us to support their regulated bioanalysis studies.
Creativity in Solving Scientific Problems
Our method development team approaches every compound with creativity, innovation, and years of scientific knowledge, allowing us to solve challenging scientific problems, including the detection of amino acids, peptides, steroids, and cephalosporins.
Access to Experts
Our clients have direct access to the expert scientist overseeing their regulated bioanalysis study at all times. A knowledgeable Principal Investigator (PI) and dedicated Project Coordinator (PC) are assigned to every project we conduct and provide regular communication and status updates.
State-of-the-Art Facilities & Equipment
Our 34,000-square foot headquarters is home to sample preparation laboratories, an immunoassay laboratory, and mass spectrometry laboratories. Our instrumentation for regulated bioanalysis includes liquid chromatography–tandem mass spectrometry systems, HPLC systems, MSD instruments, and Molecular Devices plate readers.
Quality Scientific Data & High Success Rates
All of our GLP-regulated bioanalysis studies are audited by an experienced, independent member of our Quality Assurance Unit (QAU), and every study meets or exceeds the criteria set forth by our Standard Operating Procedures (SOPs) and all applicable regulations. None of the studies submitted to the USFDA for approval have had any bioanalytical issues when bioanalysis was performed by BioAgilytix.
Robust Quality Control
We have a 20-year history of GLP compliance. BioAgilytix has been successfully inspected by the United States Food and Drug Administration (USFDA) for compliance with Good Laboratory Practices (GLP) four times.
Dedicated Client Services
We conduct annual client surveys to ensure that we consistently meet expectations, and the results show high client satisfaction, with praise for our communication, high-quality data and results, and quality deliverables.
BioAgilytix by the Numbers
The numbers are clear: BioAgilytix is a highly reputable, experienced partner for regulated
bioanalysis studies.
100% program approval rate by USFDA
0
regulatory complaints
over 4 FDA audits
6300
+
regulated studies
supported
20
+
years experience
50
%
of company resources
dedicated to lab
2400
+
methods developed
1500
+
validated assays
