Dhaval Tripathi Email & Phone Number

Ahmedabad, Gujarat, India

Ahmedabad, Gujarat, India

Effectively manage the product development for the products assigned to the group and co-ordinate with partners to ensure completion of project on time.Monitor the progress of the projects and pro-actively visualize the possible road blocks and have back up action plan, co-ordination with all stakeholders to move the projects smoothly and ensure that the resources assigned to projects are adequate to meet project objectives.Acts as a resource to provide direct technical and… Show more Effectively manage the product development for the products assigned to the group and co-ordinate with partners to ensure completion of project on time.Monitor the progress of the projects and pro-actively visualize the possible road blocks and have back up action plan, co-ordination with all stakeholders to move the projects smoothly and ensure that the resources assigned to projects are adequate to meet project objectives.Acts as a resource to provide direct technical and scientific support to both development and manufacturing partners and company projects. Regular feedback from partner through telecom/e-mail/partner visit on project progress. Manage all project and partner communications including team meetings, partner meetings, progress reports and measure project performances.Ensuring the completion of projects within agreed timelines, cost, and resources.Cooperate with third party partners and potential new partners to develop improved products or product manufacturing technologies and scope out new product development opportunities.Working with both Business and Technical functions, uncover new potential product development opportunities that are commercially viable.Lead and execute commercial operation having Site transfer activity of projects from one site to another site with strong coordination and deep knowledge of regulatory guidance including alternative API source, addition of new packs, modification of manufacturing process, support in analytical and process validation activity and coordination with commercial launch activity from new site.Assists in data generation, analysis, data summary and interpretation of results, and formulation of appropriate recommendations for emerging markets. Works with executive management to align strategic objectives and priorities, and establish timelines in support of new and ongoing department projects. Show less

Ahmedabad Area, India

Working as Product development manager for emerging markets like Canada, Europe, Australia

Ahmedabad, Gujarat, India

Experience in development of generic solid oral dosage forms as per ‘Quality by Design’ principles; Experience of over 18 generic drug product development and successfully filled in US ; including (NCE-1) and First To Market (FTM), Strong understanding of pre-formulation; expertise and exposure to different manufacturing techniques and solid dosage forms; Good knowledge and experience in development of MUPS using extrusion & bottom spray techniques and other complex systems like MUPS (Multi… Show more Experience in development of generic solid oral dosage forms as per ‘Quality by Design’ principles; Experience of over 18 generic drug product development and successfully filled in US ; including (NCE-1) and First To Market (FTM), Strong understanding of pre-formulation; expertise and exposure to different manufacturing techniques and solid dosage forms; Good knowledge and experience in development of MUPS using extrusion & bottom spray techniques and other complex systems like MUPS (Multi Unit Particulate System) tablets, Bilayer Tablets, Modified release formulation and pelletization process (Wruster coating). To do exhaustive literature search and to prepare abstract for initiation of development process. Having knowledge on patent search and making non-infringing formulation. Interpret results, evaluate data, draw relevant conclusions; ensuring compliance with product quality, performance and efficiency. Online documentation related to new product development, Preparation & review of draft specification and regulatory conformation form, Product development report, TT documents including MFR.Co-ordination with relevant departments like ADL, Regulatory, Purchase, and product management for timely completion of projects.planning and execution of Developmental, scale up batches; execution of demonstration / submission batches (exhibit batches) to meet desired timelines; monitoring stability results; preparation and review of documents related to product development report as per QBD and current USFDA guidance; preparation of Batch manufacturing records ; Respond FDA query with scientific justification and anticipate upcoming FDA queries and readiness for FDA IR and CR response . Show less

Ahmedabad , Gujarat

Working as research scientist for US market

Ahmedabad , Gujarat

Working as executive for US market

Gandhinagar, Gujarat, India

M.Pharm, Pharmaceutics

Master Of Pharmcy, Pharmaceutical Technology, First Class