Comprehensive Pharmaceutical Testing
Our pharmaceutical division is equipped with state-of-the-art instrumentation and staffed by experienced analytical scientists. We support pharmaceutical manufacturers, contract research organisations, and regulatory affairs teams with a full suite of testing services aligned with ICH, USP, EP, FDA, and EMA guidelines.
Method Development
Development of robust, fit-for-purpose analytical methods for active pharmaceutical ingredients (APIs), drug products, and excipients. We design methods for assay, related substances, dissolution, and more.
Method Validation
Full validation packages covering specificity, linearity, range, accuracy, precision (repeatability & intermediate), limit of detection, limit of quantitation, and robustness.
Nitrosamine Testing & Risk Assessment
Comprehensive nitrosamine testing and impurity risk assessments for drug substances and drug products in compliance with ICH M7, EMA, and FDA guidelines. Includes root cause analysis and confirmatory testing.
Heavy Metals Risk Assessment
Elemental impurity profiling using ICP-MS and ICP-OES. Risk assessments and confirmatory testing for oral, parenteral, and inhalation drug products.
Residual Solvents
Quantitative determination of residual solvents in APIs and drug products using headspace GC-FID and GC-MS. Class 1, 2, and 3 solvents covered.
Extractables & Leachables
Systematic extraction studies and leachable profiling for primary packaging materials, container-closure systems, and drug delivery devices.
Microbiology & Bioburden
Total aerobic microbial count, total yeast and mould count, specified organism testing, sterility testing, and bioburden determination for pharmaceutical products.
Bioassay & Cell Lines
Biological activity assays and cell-based potency testing. Cell line authentication, mycoplasma testing, and in-vitro cytotoxicity studies.