Karthik Chandrappa

Background

About Karthik Chandrappa

Development of a Generic formulation from literature search to commercialization. Patent search & Preparation of pre-product development strategy. To conduct the pre-formulation study for the product development. To prepare prototype formulations based on the pre-formulation study. Planning and execution of developmental trials, for achieving desired dissolution profile, stability & bio-equivalence. Interpretation of Bio-equivalence data. Preparation of submission batch documents such as Master formula record, Stability protocol, etc. Execution of process evaluation batches and exhibit batches. Preparation of product development report by Quality by Design. Acquainted knowledge in USFDA, EMEA & ICH Guidelines. Implementation of QbD concepts mainly focusing on Quality target product profile, Critical quality attributes, Critical material attributes, Critical process parameters and Control strategy for development of drug product for US market as per current regulatory requirement. Knowledge on Design of experiments and Design expert software. Ability to work individual and manage team (co-ordination and co-working with cross functional teams).