Sumit Saha

Background

About Sumit Saha

I am a pharmaceutical product development scientist having a good experience in the solid oral dosage forms for US market. I have a good understanding of formulation development, process optimization, scale-up, and technology transfer. I have gained a good knowledge of current regulatory guidances, ICH guidelines and requirements of ANDA submissions. My current job profile involves application of fundamental scientific principles to formulation & process design and development, optimization of formulation through rationale experimental planning, thoughtful implementation and clear data interpretation leading to development of stable and bioequivalent drug product. It is followed by technology transfer to manufacturing site/s, execution of scale-up and exhibit batches, pivotal bioequivalence studies, and support to ANDA filings. I am a self-motivated individual with strong organizational skills. A proven team player with effective interpersonal skills and good verbal & written communication skills. I have the ability to work independently, prioritize assignments to meet required timelines. Specialties: Roll compaction and Fluidized bed technologies.