Niteshkumar Patel Email and Phone Number

• Worked on 9 ANDA including Para IV projects. Responsible for 4 ANDA filling (approval received).• Drive the project management process for new and existing projects during initiation, planning, execution, monitoring, control and closing of the project.• Work corss-functionally (RA, IPR, DQA, Doc cell, ADL, Purchase, Packaging, PMT) to define project objectives, determine appropriate development requirements, design research plan and test.• Develop & implement robust processes to bring out efficiencies in the delivery of projects.• Thorough understanding in unit operations like FBP (Wurster and Top spray), RC, DC, RMG, IGL, Mono/Bilayer compression, Functional/Film coating, MUPS and pellatization, Capsule filling.• Co- ordination for scheduling of exhibit batches in pilot and production facility.• Provide technical support to resolve problem during SU/EB manufacturing & technology transfer.• Co-ordination with regulatory, marketing and packing departments for launching of new products.• Evaluate data generated from formulation studies, recommends critical processing parameters/Bio clinical evaluation, manufacturing process and proposed specifications for SU/EB.• Knowledge of QbD, cGMP, GLPs, FDA/ICH guidelines SOP, controlled substance handling procedures and other regulatory requirement governing pharmaceutical manufacturing.• Ensure accurate and efficient document management of all project activities including but not limited to study reports and project learning.

• Development of solid oral/Liquid oral dosage form for domestic and Semi regulated market.• Market Complain Investigation for domestic formulations.

• Handled solid orals, liquids projects at R&D entry level• Got opportunity to serve at production level in cGMP plant.