Gain Strength in Depth.
From preclinical research through clinical development you can get accurate, on-time results at every stage of the continuum to advance your program. Leverage our expert scientific team, state-of-the-art technologies and global resources to deliver high-quality results.
Meet your program’s requirements while complying with FDA Crystal City and current regulatory guidelines. Put the #1 ranked bioanalysis service provider to work on your drug development effort, backed by a team that develops 600+ methods and completes 1,400+ studies comprised of 950,000+ samples annually for small molecule programs.
Small Molecule Bioanalytical Services:
Meet your program’s requirements while complying with FDA Crystal City and current regulatory guidelines. Put the #1 ranked bioanalysis service provider to work on your drug development effort, backed by a team that develops 150+ methods and completes ~300 studies comprised of 350,000+ samples annually for biologics programs.
Method feasibility, development, transfer, validation and sample analysis (GLP/GCP)
Specialized LC-MS Solutions, including High-Resolution Accurate Mass spectrometry
Discovery bioanalysis (non-GLP)
Immunogenicity studies using a tiered approach:
Nonclinical toxicokinetic (TK) and pharmacokinetic (PK) studies
Clinical PK, bioavailability & bioequivalence studies
Nonclinical and clinical drug/drug interaction studies
Nonclinical and clinical pharmacodynamics (PD) studies
Pharmacokinetics/pharmacodynamics and toxicokinetics analysis
Biologics Identity Assessment/Fingerprinting:
Biologics Strength/Potency Determination:
Biologics Purity Assessment
Biologics Quality Testing
Small Molecule Performance Testing of Inhaled Products:
Small Molecule Extractable and Leachable Testing:
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