Core Analytical Services

•   Method development, validation & transfer

•   Stability programs and routine QC (ICH-aligned)

•   Advanced characterization & comparability (ICH Q6B-aligned data packages)

•   Potency, binding and advanced functional bioassays

•   cGMP batch-release testing for small molecules and biologics

Small Molecules

•   Method development & validation

•   Impurity identification & characterization

•   Assay, purity, dissolution, residual solvents

•   ICH stability studies

•   Formulation development for solids, liquids, and semi-solids

•   GMP manufacturing for solid oral dosage forms

•   QP batch release & regulatory documentation 

•   Regulatory consulting & dossier-ready documentation support

Biologics Analytical Services 

•   Deep characterization, comparability and QC services supporting development, and EU/US-aligned release

•   ICH Q6B Protein & antibody characterization 

•   Mechanistic properties determination (potency & binding)

•   PTMs, glycosylation & aggregation profiling 

•   Process- and product-related impurities 

•   QP batch release