Method Development
& Validation

Aragen has extensive experience in analytical method development and validation across a variety of platforms, including HPLC, LC-MS/MS, GC-MS, GC-FID and ICP-MS. 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 validated against SOPs and ICH guidelines, while also undergoing regular reviews by our quality assurance team. We also offer routine microbiological, antimicrobial/preservative efficacy, disinfectant efficacy and microbial enumeration tests. Customers have successfully submitted our analytical data to global regulatory agencies, including USFDA, EMA, MHRA, PDMA and TGA. Our analytical and regulatory teams provide additional support, post submission for regulatory approval.