Arindam Halder

Background

About Arindam Halder

Having 16 years' experience for complex generics and 505(b2) formulation development in ophthalmic and parenteral product development. Integrating ideation, formulation developmental strategy, preclinical strategy and outcomes interpretation, clinical-preclinical correlation, preIND, IND, clinical strategy overview, clinical and registration batch manufacturing, NDAfiling readiness, approval, commercial manufacturing, Complex generic development, scale up, ANDA filing, FDA query response and approval. Drug device combination development and filing experience. PreIND, IND and preNDA meeting experience with USFDA, Experience CBEs on post approval changes and FAR response on market recall to USFDA, Inventor of 13 patents for new drug development and own more than 10 research publications. Development, filing, query response and approval experience accross global markets like US, EU, CAD, AUS, ISRAEL, CHINA, INDIA and other rest of the world markets including major markets like BRAZ, MEXICO, SOU AFR, RUSSIA etc. Lead a group scientists in last 14 years.