Method Development
& Validation

Aragen develops and validates analytical methods across platforms including HPLC, LC-MS/MS, GC-MS, GC-FID and ICP-MS to support drug substances, drug products and related analytes. Our analytical scientists use appropriate techniques and instrumentation to quantify and qualify new chemical entities, drug substances, drug products and their related analytes. Developed analytical methods are supported by quality systems and regulatory audit readiness, with quality assurance review as per internal procedures. We also offer routine microbiological, antimicrobial/preservative efficacy, disinfectant efficacy and microbial enumeration tests. Analytical data generated by Aragen has been used to support customer regulatory submissions to global agencies. Our analytical and regulatory teams provide additional support, post submission for regulatory approval.