Shipra Malik was responsible for the preparation of Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) as well as New Drug Application (NDA) for filing to the USFDA. She worked in collaboration with the formulation and analytical division to finalize the product development strategy. She successfully filed an ANDA for NCE-1 product and was accepted by USFDA for review. I also provided life cycle management support for approved products in the USA, Canada as well as Europe.