Combined experience of more than 13 years in the field of inhalation, nasal sprays and transdermal patches.Present: (at JAMP PHARMA )Managing third party operations for inhalation and nasal product development and project management for Canada market generic (ANDS) product submissions Working in CDO, CMO / CDMO business models.Co-ordination with partners and stakeholders from different regions and different companies to adhere timelines.Technical review of development operations, partner documents and reports.In licensed dossier review in detail, gap assessment and preparation of due diligence for Canada market regulatory submissions (ANDS) as per Health Canada guidance.Active role in Health Canada queries / clarifications requests.Key role in Product launch activities (post approval).Manufacturing plant set up, layout finalisation and capacity calculations. Past: (At Zydus) Formulation and development of Pulmonary Drug Delivery System specially Pressurised Metered Dose Inhalers (MDI - Inhalation Aerosols) & Nasal Spray for US and other regulated as well as semi regulated markets.Handling of ANDA projects for Metered dose inhalers (MDI)Active involvement in planning and strategy for new projects in MDI & Nasal SprayExecution of development batches as per QbD approach to freeze the process and specifications for the productReview of analytical data and deciding the way forward.Patent review and ANDA Strategy finalization Execution of scale up, pre-exhibit, exhibit and validation batches at plant (Technology Transfer)Documentation Preparation of MFC, Process Development Report (PDR), Process Development Protocol (PDP), Batch Manufacturing Record, characterization protocol, In vitro BE Study protocol etc.Co-ordination with Analytical, PK, PMT, supply chain management team for smooth execution of the projectFormulation and Development of Transdermal and Topical patches (TDDS) for US Market - At Zydus Technologies Limited