Pradeep Karatgi

Director of Business Development

Experience: 16+ years, with experience in NCE development and NDA development and filing

Pradeep is an expert in formulation development for NCEs, INDs and NDAs, and in business development and strategy. He is also actively involved in the scale-up and process characterization for some of the top global pharmaceutical organizations.

With his previous employers, he has played a pivotal role in the research related to new drug development as well as generic formulation development as well as generic formulation development. Additionally, he has led NCE formulation development for internal projects, including both – early phase (Phase I and Phase II) as well as late phase (Phase III) – clinical stages, and is involved in pre-formulation studies and pre-clinical formulation development for NCEs.

Pradeep is highly experienced in management of IP and business-related legal functions of the organization, including technical report writing and review. He is also well versed in applying statistical design using design of experiments (DoE) at different stages of formulation and process development. Additionally, he is also an expert in development of cytotoxic compounds, nanotechnology and drug complexation using cyclodextrins.

Pradeep has seven international patents to his credit, along with multiple national and international publications and presentations, and has been a speaker at multiple platforms, for lectures with prime focus on Quality-by-Design.