About the role
Analytical Method development, validation and method equivalency of Inhalation Products for inhalation tests, related substances and assay. (pMDIs, DPIs, SMIs and Nebulizers) ⮚ Performed Drug product Characterization study (DPC) and IVBE study for US, Europe, and Canada market for Inhalation products. ⮚ Method development, validation of Spray Pattern, Plume Geometry by Spray View. ⮚ Method development and validation of Delivered Dose uniformity. Aerodynamic Particle Size Distribution (APSD) By ACI and NGI ⮚ Familiar with Nitrosamines Impurities, Extractable & leachable, ICH Guidelines and Regulatory Submissions.