A successful Technology Transfer ensures the quality of product during the entire life cycle of manufacture and validation, in accordance with cGMPs, providing predictable and consistent operation of the processes. It is based on the principles of FDA/ICH guidelines, involves knowledge transfer, science and risk-based approaches which ensure a comprehensive and systematic transfer of information and documentation between transferring site and receiving site.
Kamat Pharma specializes on TT of injectable products, particularly of the lyophilized products, from laboratory to manufacturing, and then to commercialization using sound quality-by-design (QBD) principles.
With its extensive experience in technology transfer, Kamat Pharmatech offers solutions and implementation of projects to numerous Contract Manufacturing Organizations (CMOs) throughout the United States, Europe, and in India. Such familiarity with the CMOs brings together the best in value and timeliness for potential clients. |