Bioanalytical Sciences

Bioanalytical sciences measure drugs, metabolites, antidrug antibodies, and biomarkers in biological matrices so pharmacokinetic, exposure, and response claims rest on real numbers. Method design, validation, and sample handling decide whether clinical and nonclinical conclusions survive regulatory scrutiny. Weak bioanalysis creates noisy PK, uninterpretable PD, and late discovery that an assay cannot support the claim you need for dose selection or labeling discussion.

Viltis supports bioanalytical strategy and oversight across ligand-binding, LC-MS/MS, and related platforms used in regulated studies. We help define method fitness for purpose, validation expectations under applicable FDA and EMA guidance, incurred sample reanalysis and stability considerations, and how sampling schedules interact with assay LLOQ and matrix effects. When labs are outsourced, we review protocols, validation reports, and data packages before they become filing problems. We also help clinical teams adjust sampling when the assay reality will not support the planned analysis.

Immunogenicity and biomarker assays often sit beside PK methods and get less governance than they deserve. We help sponsors set fitness-for-purpose expectations for those assays, including when full validation is warranted versus when a qualified exploratory method is enough. Clear intent prevents fights later about what a result can support in a filing or an investigator brochure update. We document method limitations explicitly so clinical and regulatory teams do not over-read results the assay cannot support.

Bioanalytical support typically includes

• Method development and validation oversight
• Fitness-for-purpose and platform selection input
• ISR, stability, and sample logistics review
• PK and biomarker data quality assessment
• CRO lab audit and performance oversight
• Alignment with clinical protocol sampling plans
• Support for regulatory questions on methods

Reliable bioanalysis is quiet infrastructure for every exposure claim in your program. We help sponsors keep methods matched to decisions (dose finding, immunogenicity, or labeling support) without over-validating assays that do not change the next gate. When methods transfer between labs or evolve mid-program, we help preserve comparability so historical data remain usable. If PK or immunogenicity data look unstable, we start with method performance and sample handling before blaming the molecule or the clinical design.