Bioanalysis & Analytical CMC

Generating Decision-Ready Analytical Data

Analytical chemistry underpins every stage of drug development – from compound characterization through formulation optimization to regulatory submissions. Whether developing methods for quality control, profiling impurities for safety assessment, or conducting bioanalysis for PK studies, analytical work must be fit-for-purpose, scientifically defensible, and appropriately documented.

Biotts provides bioanalytical and analytical CMC services supporting pharmaceutical and biotech partners across development stages. Operating from a GMP-certified facility with HPLC/UHPLC, LC-MS/MS, NMR, and additional instrumental capabilities, we generate analytical data packages structured to support regulated development and regulatory submissions where applicable.

Our approach emphasizes method appropriateness for intended use. Early development work may use fit-for-purpose methods optimized for speed and information content. As programs advance toward regulatory submissions, methods are validated following ICH guidelines (Q14, Q2(R2), M10) where appropriate, with documentation suitable for CMC sections of regulatory filings or bioanalytical reporting.