Inhalation Analytical Department • Setup of analytical facility for Respiratory research and entire thoroughly experience of analysis of device combination product ( MDI & DPI) • Training to team inhalation testing analysis in GLP practices and according to project knowledge to team about guidance document like CMC, product specific draft guidance and individual monograph.• Support formulation team device characterization in MDI/DPI product. • Development and validation of MDI analytical method for all inhalation test item including automated actuation for DDU and APSD analysis. • Review of development, Routine and stability studies of MDI & DPI method transfer and validation of Inhalation analytical method in QC and other technical documents.• Deep experience in analytical data interpretation for MDI/DPI product and design support formulation team to design the RD trials. • Review and manage of outsource CDMO activity related document like Extractable and leachable and Particle Morphology (Q3) analysis.• Develop Method Invitro-In vivo Co-relation analytical method using dissolution, Alberta Throat Model and BRS inhalation profile. • Executed Analytical Work Activity the project according to US, EU and domestic market.• Protocol preparation, execution of analysis and report preparation characterization studies and IV/BE study according to projects. • Preparation of Method development reports, Standard test procedure, specification finalizations, equivalency report, Protocol validation /Workability protocol.• Investigation of abnormal data and design of Study (DOE) to find the conclusion. • Support to smoothly transfer Analytical Method to QC Laboratory.

• Handling Team for metered dose and nebulization research work. Allocation of work and trouble shooting in day to day activity. • Support to formulation team about Nebulisation device development.• Review of development, Routine and stability studies of MDI and Nebuliser projects.• Executed the project according to US, Europe or domestic market.• Training to team inhalation testing analysis and according to project knowledge to team about guidance document like CMC, EMEA, ICH etc.• Plan product characterization and IV/BE study according to projects. • Preparation of Method development reports, Standard test procedure, specification finalizations, equivalency report, Protocol validation /Workability protocol.

Setup of analytical facility for pulmonary research (metered dose inhalers)• Analysis of metered dose inhaler for U.S. E.U. And R.O.W countries as per the regulatory requirement for ANDA submission• Analytical method development and validation for metered dose inhaler and Nebuliseranalysis• Calibration, maintenance and trouble shooting of HPLC, U.V, I.R, Motic Microscope and KF Autotitrator• Training and validation of trainee analyst• Performing of stability analysis of cascade impactor, new generation impactor and Delivered-Dose Uniformity etc for inhaler samples as per pharmacopeia guidelines• Preparation of validation protocols and study protocols as per pharmacopeia guidelines• In-house analytical instrument development and vendor qualification• Impurity Profiling of Meter Dose inhaler and Respules• Assay and Impurity Method development of Meter Dose inhaler by HPLC• Raw Material Analysis as per PharmacopeiaInstruments Handled:• High Performance Liquid Chromatography.Shimazadu operating software: Class V.P, ChromleonAgilent operating software: HP chem., ChromleonDionex Ultimate 2000 & 3000 with Chromleon• Infrared Photo spectromete : Make Shimazadu• Spray view (For spray pattern & spray view ) : Oxford lasers• U.V Photo spectrometer Make Shimazadu • KF Autotitrator and Coulometer Make Metrohm and Metlar• Particle Size Analyzer Make Malvern Masrtersizer• Microscope Make Motic

In-house analytical instrument development and vendor qualification• Performing of stability analysis of cascade impactor, new generation impactor and Delivered-Dose Uniformity etc for inhaler samples as per pharmacopeia guidelines• Impurity Profiling of Meter Dose inhaler• Assay and Impurity Method development of Meter Dose inhaler by HPLC