Bhupesh Pratap
Senior Principal Scientist
Medical
Perrigo Company plc
India
Biography
Senior Principal Scientist Company Name Perrigo Company plc Dates Employed May 2017 – Present Employment Duration 5 mos Location Mumbai Area, India •Manage complete outsourcing of bioavailability/Bioequivalence and clinical studies for generic/NDA/IND dossier submissions. • Evaluation of the potential Rx to OTC switch and helping the business development team with the decision making. • Helping the development teams with filing for NDA & 505 b(2) NDA route, co-development projects for partnering companies and novel idea based products for potential out-licensing. • Defining and Implementation of global biopharmaceutical strategy and tools across dosage forms and filing strategy. • Utilization of GASTROPLUS and DDDPlus to understand release kinetics and to predict in-vivo performance of drug delivery systems and dosage form for selection of ideal candidate for further development. • Characterization of in vitro release profile and setting up the dissolution/release specification using IVIVC, model dependent/independent method and Bootstrap methods • Implementation of lean sigma to reduce the product development time line and early identification of the critical process.
Research Interest
Pharmaceutical company
