<ul><li>Responsible for development of stable and robust formulations across various dosage forms including Oral Solids.</li><li>Formulation excipient screening, stability compatibility studies, bio-analytical characterization, pharmaceutical testing, and formulation transfer to pilot- and GMP production.</li><li>Conducting the trouble-shooting of formulations/products in terms of composition (formulation) and process (method of manufacturing) issues.</li><li>Applying design of experiments (DOE) in developing formulations and processes according to FDAs Quality by Design (QBD) requirements.</li><li>Carrying out the pre formulation and formulation development studies for the selected drug candidates to support NDA and ANDA filings of IR/SR/ER/MR formulations.</li></ul>

Lead-Formulation Development