Venkatesh Reddy Email and Phone Number

Formulation Team leader with 13+ years of research experience solid(Tablets, Softgel Capsules,Pellets) and liquid orals for US, Europe market. Designing, conducting and supervising formulation development, process development, process optimization, scale up and manufacturing of various complex generic and 505b2 product for osmotic RLD, Soft gelatin capsules and Liquid oral Dosage forms)Hand on experience on QbD / DOE development (Oral dosage forms like Soft gel, Oral Liquids, MUPS, Immediate release, Extended release, Bilayer, Fixed dosage combinations, minitablets, matrix tablets principles for optimization of poorly soluble, potent, highly soluble drug formulation and process variables using (by using design expert software). Prepared and reviewed Batch Records, Batch Packaging Records, Product Development reports (PDR), SOPs, Stability protocols, Raw material specifications, Packaging material specifications and In-process/ Finished product specificationsExperience with physicochemical characterization of API, pre- formulation, formulation (solubility, dissolution studies, permeation, compatibility, rheology) and stability studies. Complete Implementation of bio pharmaceutical principles during the formulation development. Thorough understanding and implementation of FDA , USP, ICH, SUPAC, cGMP Guidelines