•Led and managed a development team focused on generic solid oral and liquid oral forms across various therapeutic categories, ensuring high performance and innovation.•Implemented development protocols in strict accordance with US and European regulatory requirements, successfully scaling up dosage forms to manufacturing levels.•Expertly handled agency queries and maintained consistent communication with regulatory bodies throughout various stages of development and European… Show more •Led and managed a development team focused on generic solid oral and liquid oral forms across various therapeutic categories, ensuring high performance and innovation.•Implemented development protocols in strict accordance with US and European regulatory requirements, successfully scaling up dosage forms to manufacturing levels.•Expertly handled agency queries and maintained consistent communication with regulatory bodies throughout various stages of development and European submissions, particularly for liquid and solid oral formulations.•Demonstrated proven expertise in troubleshooting diverse dosage forms and developing 505(b)(2) applications for the US market, ensuring regulatory approval and market readiness.•Successfully developed numerous liquid and solid products from project inception through to product development, process development, registration batches, query responses, and final launch, ensuring seamless progression and compliance. Show less

•Played a pivotal role in establishing the Research and Development center, overseeing the purchase and installation of advanced formulation and analytical equipment to ensure state-of-the-art facilities.•Led the development of generic topical and solid oral products, meticulously adhering to regulatory requirements to ensure compliance and efficacy.•Conducted comprehensive stability evaluations to guarantee the quality and longevity of formulations.•Identified and collaborated with… Show more •Played a pivotal role in establishing the Research and Development center, overseeing the purchase and installation of advanced formulation and analytical equipment to ensure state-of-the-art facilities.•Led the development of generic topical and solid oral products, meticulously adhering to regulatory requirements to ensure compliance and efficacy.•Conducted comprehensive stability evaluations to guarantee the quality and longevity of formulations.•Identified and collaborated with Contract Manufacturing Organizations (CMOs) for technology transfer, ensuring seamless production processes.•Directed the development of outsourced drug products, maintaining strong partnerships with CMOs to optimize product quality and regulatory compliance. Show less

•New Formulation Development (Parenteral including NDDS Dosage form,Transdermal, Solid Oral Technology ): Development of Formulation for US and Europe market Formulation strategy preparation and risk assessment and analysis .Prefomulation activities, designing skin permeation studies, Uptake Study and transmission study stability monitoring and evaluation of stability data and interpretation of analytical data.In vitro dissolution of Complex injectable, Transdermals and Topical… Show more •New Formulation Development (Parenteral including NDDS Dosage form,Transdermal, Solid Oral Technology ): Development of Formulation for US and Europe market Formulation strategy preparation and risk assessment and analysis .Prefomulation activities, designing skin permeation studies, Uptake Study and transmission study stability monitoring and evaluation of stability data and interpretation of analytical data.In vitro dissolution of Complex injectable, Transdermals and Topical products•Process Development: Design, develop and interpret experiments based on DOE for process optimization.Development of transdermal , Complex injectable and topical products complying agency requirements and take it forward to mfg scale. Show less

•New Formulation Development (Transdermal Technology & Compex Injectables ): Development of Formulation for US market using QbD ApproachFormulation strategy preparation and risk assessment and Analysis .Prefomulation activities, designing skin permeation studies, Uptake Study and transmission study, stability monitoring and evaluation of stability data and interpretation of analytical data.•Process Development: Design, develop and interpret experiments based on DOE for… Show more •New Formulation Development (Transdermal Technology & Compex Injectables ): Development of Formulation for US market using QbD ApproachFormulation strategy preparation and risk assessment and Analysis .Prefomulation activities, designing skin permeation studies, Uptake Study and transmission study, stability monitoring and evaluation of stability data and interpretation of analytical data.•Process Development: Design, develop and interpret experiments based on DOE for process optimization.Evaluation of CMA and CPP on Product Quality Summary.Process Scale up and Respond to FDA query response Show less

•New Formulation Development (Transdermal Technology ): Development of transdermal dosage complying agency requirements and take it forward to mfg scale.Formulation strategy preparation and risk assessment and Analysis .Prefomulation activities, designing skin permeation studies, Uptake Study and transmission study stability monitoring and evaluation of stability data and interpretation of analytical data.•Process Development: Design, develop and interpret experiments… Show more •New Formulation Development (Transdermal Technology ): Development of transdermal dosage complying agency requirements and take it forward to mfg scale.Formulation strategy preparation and risk assessment and Analysis .Prefomulation activities, designing skin permeation studies, Uptake Study and transmission study stability monitoring and evaluation of stability data and interpretation of analytical data.•Process Development: Design, develop and interpret experiments based on DOE for process optimization.Evaluation of CMA and CPP on Product Quality. Show less

-Formulation Development of Transdermal dosage forms-Literature Search, Planning of Preformulaton studies -Working on solvent based and Aqueous based Transdermal Product Development For US market using QbD approach-Well experienced in taking lab scale batches . Scale up and handling of exhibit Batches .-Packaging Development for Transdermal Patches as per Regulatory requirements.-Experience in Modified Solid Oral Dosage Form and Film forming Topical Dosage forms for US… Show more -Formulation Development of Transdermal dosage forms-Literature Search, Planning of Preformulaton studies -Working on solvent based and Aqueous based Transdermal Product Development For US market using QbD approach-Well experienced in taking lab scale batches . Scale up and handling of exhibit Batches .-Packaging Development for Transdermal Patches as per Regulatory requirements.-Experience in Modified Solid Oral Dosage Form and Film forming Topical Dosage forms for US market.-Experienced in Scale up Batches and Exhibit Batches Show less

Development of Oncology solid oral product developmentDifferent Solid oral dosage forms development as per dossier requirements