Bratakatha Nath

• Pre-formulation study, literature survey and data mining for development of new formulation.
• Characterization of reference product.
• Formulation development, process optimization, and stability studies.
• QBD application in formulation development.
• Developing bioequivalence criteria by conducting thorough literature studies and comparative
• Evaluations of reference and generic medicines.
• Optimization of manufacturing process.
• Reviewing the required materials associated documents and procurement.
• ANDA submission requirements.
• Collaboration with analytical development team.
• Risk assessments for genotoxic, elemental, and nitrosamine impurities.

• Application of statistical approaches for process optimization (DOE, QbD) at small scale and translation of small scale results to process scale up.
• Execution of NCE, para III, para IV projects, and generic projects
• Through study and understanding of patents and preparation of workable strategies for circumventing the claims of patents para III, para IV, and NCE-1 filing.
• Installation, Operation, and qualification of different laboratory machines, including capsule filling and coating machines

• Expedite stability study of new products and existing products under development
• Development and validation of manufacturing procedures for products under development with the help of the in-process Control (IPC) and QC departments
• Troubleshooting for current products in PO batches and reformulation activities
• Prepare and update SOPs in compliance with the relevant guideline of DGDA, WHO, USFDA, and ICH.

• Mentoring students & Student safety

• Lab inventory management

• Assisting students in conducting practical experiments.

• Specimen and sample preparation & Handling Research, analysis & Reporting operations

• Equipment management

• Tutored struggling students individually and in small groups to reinforce learning concepts.