Manish D.

Overall 15 Years of Experience in Pre-formulation and Formulation Development of New Chemical Entities and Generic product development across various Pharmaceutical Industries. High experience in development and validation of drug product. Good multidisciplinary background in different areas of the drug discovery from RnD and commercial. Specialties: 1.Formulation Development of New Chemical Entities for Late Stage Clinical Phase. 2.Formulator for NCE molecules Phase I, Phase II and Phase III 3.Formulation Development for First-in-Human Clinical dosing. 4.Formulator for Generic product development. 5.Expertise for overseeing all the technical aspects of development and manufacturing. 6.Product scale up and technology transfer. 7.Process development, validation and continous improvement. 8.Analytical testing 9.Project management. [login to view URL] of externa partners/TPC/CRO/CMO. Working toward lean sigma yellow belt certification.