Experience of Formulation Development of Generic Solid Oral Drug Product like Immediate release formulation, modified release formulation for regulated market like USA, Europe. Experience of Scale-up, Process Validation and Technology Transfer.
To plan, execute and monitor Literature survey, Patent status, API and Innovator Characterization and Preformulation study, scale up and Exhibit batches for US and Europe market.
Designs and undertakes quality scientific experimentation to develop robust solid oral dosage formulations and processes Using current approach like Quality by design (Qbd), Design of experiments (DOE), Risk assessments etc. Evaluation of Analytical results and trouble s...