Nitrosamine testing, including NDSRI analysis, non-volatile extractables and leachables, and determination of genotoxic impurities, is performed using highly sensitive LC-MS/MS.

Extensive expertise in method development and validation as per ICH guidelines, with proven experience in addressing regulatory queries and related activities.

Zone IVb long-term stability studies for all pharmaceutical and nutraceutical products, fully compliant with 21 CFR Part 11, supporting regulatory registration requirements.

Accelerated stability studies for all pharmaceutical and nutraceutical products, fully compliant with 21 CFR Part 11, supporting regulatory registration requirements.

Photo stability studies as per ICH guidance for all pharmaceutical and nutraceutical products, supporting regulatory registration requirements.

Volatile Organic Compounds analysis using Gas Chromatography with FID detector and Headspace, supporting all residual solvent testing needs.

In-vitro studies using USP I & II offer complete solutions for CDP studies, routine testing, biorelevant dissolutions, discriminating dissolutions, and more.

We provide support for all types of manual titration-based chemical determinations in pharmaceuticals, raw materials, and nutraceuticals.

Routine analysis of DS and DP of peptide products such as GLP-1 injections, with expertise in providing end-to-end guidance for successful development and registration.

We provide complete evaluation including DMF review, critical parameter testing, and a comprehensive report with recommendations to support cost-effective and compliant raw material source selection.