Prabhakar Reddy Email & Phone Number

Technical and scientific leader with more than 30 years of combined pharmaceutical industry and academic research experience, with focus on both analytical and bioanalytical areas to support drug discovery and development. Prabhakar has served in several impactful technical and management positions, working with companies ranging from early-stage startups, large generic, academic drug discovery, CDMO and large multi-national corporations. Experience in analytical method development, validation, impurity characterization, dissolution method development and validations, technology transfer, regulatory document (IND/NDA/ANDA) preparations and investigations. Cross-functional team management with formulation, QA/QC, regulatory, manufacturing and others. Specialized in managing CMO/CRO/CDMO by partnering with them for development and manufacturing of drug substance, drug product and clinical supplies. In depth knowledge of ICH and FDA guidelines related to small molecule CMC activities. A team leader with strong organizational, communicational, and people development skills. Currently, working at USP to bring affordable Complex Generics to the market by working with industry as well as with regulators.

Listed skills include Hplc, Pharmaceutical Industry, Analytical Chemistry, Technology Transfer, and 22 others.