We provide comprehensive analytical chemistry, pharmacokinetic, and bioanalytical services for the identification, purity assessment, potency determination, and impurity profiling of test items used in pharmaceutical, medical device, and toxicology studies. Our capabilities include advanced chromatographic and spectroscopic characterisation techniques such as HPLC, UPLC-MS/MS, GC-MS, and related analytical platforms to support qualitative and quantitative analysis of active ingredients, residues, and impurities. In addition, we perform physical characterisation studies including pH, density, viscosity, particle size, and osmolality measurements, as well as extractables and leachables evaluations and chemical characterisation of medical devices in accordance with ISO 10993-18:2020 and ISO 10993-12:2021 requirements.

Our laboratory also supports nonclinical development programs through validated analytical and bioanalytical testing aligned with international regulatory expectations including ICH Q6A, ICH Q2(R2), FDA Bioanalytical Method Validation Guidance, and 21 CFR Part 211. Pharmacokinetic and toxicokinetic studies are conducted for both single-dose and repeat-dose applications according to OECD TG 417 and ICH S3A frameworks, enabling integration of exposure data with repeated-dose toxicology findings. In addition, we offer safety pharmacology core battery assessments covering cardiovascular, central nervous system, and respiratory endpoints in line with ICH S7A guidance, delivering reliable, regulatory-ready data to support product safety and performance evaluations.