Small Molecule Testing Services

Small molecule testing covers the analytical and bioanalytical work required to characterize, qualify and release small molecule and peptide therapies across the drug development lifecycle. This includes method development, validation and transfer, impurity and trace-level analysis, bioanalytical support for clinical studies, and batch release and stability testing for active pharmaceutical ingredients, raw materials and finished products.

We deliver these services across solid oral dosage forms, liquids and parenterals, providing phase-appropriate support aligned with global regulatory expectations.

We provide analytical and bioanalytical support across the full drug development lifecycle, from early discovery through preclinical toxicology studies, Phase I–IV clinical trials, and into commercial release. Our laboratories operate under GLP, GCP and GMP conditions as appropriate to each stage, supporting both clinical and commercial supply through batch release and stability programs.

Our analytical methods are developed, validated and transferred in line with ICH guidelines and applicable GLP, GCP and GMP standards. Impurity and trace-level testing is performed in accordance with relevant ICH guidance, including:

• ICH M7 for genotoxic impurities
• ICH Q3D for elemental impurities
• ICH Q3A and Q3B for degradants

We also apply sensitive methods for nitrosamines, PFAS and other contaminants of regulatory concern.

We provide bioanalytical testing to support pharmacokinetic (PK) and pharmacodynamic (PD) studies, alongside biomarker analysis. Our methods use advanced LC-MS/MS technology and hybrid assays, supporting high-throughput sample analysis and generating data suitable for regulatory submissions.

Our testing capabilities cover all major formulation types, including solid oral dosage forms, liquids and parenterals. This enables integrated analytical support across drug substance and drug product, regardless of formulation pathway.