Dr. Prashant Shinde Email & Phone Number

Over 15+ years experience in Formulation development of various drugs into different dosage forms for US Market (ANDA), European (EU), WHO, ROW, domestic market (DCGI and OTC products )Understanding knowledge of product development.Good understanding and pharmacokinetics and dissolution with respect to BE study.JOB OBJECTIVE:To be a part of dynamic and structured research team in Pharmaceutical industry working on NDDS / F & D that offers growth and learning opportunities. A strong motivation skill along with strong desire to work in the organization like yours by constant learning innovative ideas of research.PROJECTS HANDLEDVarious formulations of different categories of drugs like Anti-retroviral (ARV),Anti-hypertensive, Anti-TB Antidiabetics, Antimalerial and antibiotics, Anti Rheumatoid, vitamins etc.Job Activities :Job profile includes strategy development and design, preformulation study, formulation development,selection of discriminatory dissolution condition, technology transfer to manufacturing plants,and execution of filling/launch batches.Provide technical input to respond to regulatory deficiency. Identifying and troubleshooting the critical problems during formulation development cycle, commercial validation batches.Formulation Development into dosage forms like Conventional tablets, enteric coated tablet, Dispersible tablet, Chewable tablets, extended release tablets, Tri Layer tablets, bilayer tablets, Press coated tablets like tablet in tablet and inlay tablets. Capsules, Mouth dissolving granules, Eye drops, parenteral products. Extensive coordination with different cross functional teams to ensure smooth flow of projects leading to filing.Patent search and evaluation.Complete Documentation activities of the projects under investigation(Preparation of Master Manufacturing dockets, product development report , CTD, License docs, Preparation of SOP for equipment

Listed skills include Microsoft Office, Microsoft Excel, Microsoft Word, English, and 15 others.