We provide advanced analytical and bioanalytical services for the comprehensive characterisation of pharmaceuticals, medical devices, chemicals, and test materials used in nonclinical and regulatory studies. Our expertise includes identity confirmation, purity assessment, potency determination, and impurity profiling using state-of-the-art chromatographic and spectroscopic techniques such as HPLC, UPLC-MS/MS, GC-MS, and related analytical platforms. In addition to qualitative and quantitative active ingredient analysis, we perform physical characterisation studies including pH, density, viscosity, particle size, and osmolality testing. Chemical characterisation and extractables/leachables evaluations are conducted in accordance with ISO 10993-18:2020 and ISO 10993-12:2021 requirements to support the biological safety assessment of medical devices and biomaterials.

Our services further extend to method validation, pharmacokinetics, toxicokinetics, safety pharmacology, and bioanalytical support under internationally recognised regulatory frameworks including ICH Q6A, ICH Q2(R2), OECD TG 417, ICH S3A, and ICH S7A. We support both single- and repeat-dose pharmacokinetic studies while integrating toxicokinetic evaluations into repeated-dose toxicology programs to provide comprehensive exposure and safety data. Safety pharmacology assessments covering cardiovascular, central nervous system, and respiratory endpoints are complemented by robust bioanalytical testing aligned with FDA Bioanalytical Method Validation Guidance and EMA bioanalytical validation expectations, ensuring scientifically reliable and regulatory-ready study outcomes.