Neeraj Kumar, Phd Email & Phone Number

Extensive experience in pharmaceutical solid oral and injectable drug product formulation development, technology transfers and CMC part of regulatory submissions. Well versed in project and people management. Onsite working experience with various CMO and CDMO’s across the globe situated in New Zealand, Canada, United States and United Kingdom. Skilled in developing NCE formulations for phase II/III, clinical trial formulation manufacturing (CTM) and scaling up for the commercial manufacturing and launch. Component and process selection (API, Excipient & Packing selection). Successfully, developed and submitted various time‐critical Generic plus and non‐infringing formulations falling under various submission category of {NCE‐1, 505 (b)(2)}, ANDA category by strategic contract manufacturing partnership using in‐house technology transfer or Co‐development with CDMO’s worldwide. In-licence, site transfers and third-party product development, dossier review and gap assessment for strategic planning. In‐depth understanding of projects from concept phase (bench scale) to technology transfer (cGMP manufacturing), regulatory approval and launch stage. Pre-feasibility and feasibility assessment for new product introduction and portfolio/pipeline product development.