An experienced Pharmaceutical Scientist with about 10 years of research experience of Pharmaceutical MNCs with a track record of success.Developed many innovative but cost-effective, stable and quality formulations in niche therapeutic segments.My strengths are in developing intellectual property with patent non-infringing processes development, Novel Drug Delivery Systems and applying new technology to improve the existing formulations. I have a proven track record of developing ANDAs (Generic Formulations) for highly regulated global markets. Formulation Development Expertise:• Experience on Paragraph- 4 filing of formulations and project managements.• Development of ANDAs, for highly regulated markets for all forms of Oral solid Dosage formulations. • Taste masking, Bio-enhancement and Stability improvement of pharmaceutical formulations. • Preparations and Review of Product Development Reports, Validation Protocols, Bio-Study protocols and other technical reports. • Planning and monitoring Bio-availability and Bio-Equivalnce studies and coordinating for protocol development and execution of studies. • Identifying and liaisoning with CRO/CMO for effective project management.• Setting-up new formulation R&D centre (CRO) and design of laboratories, equipment requirements and budgetary requirements etc. Specialties - Setting-up formulation R&D.- Managing multidisciplinary team of scientists.- Complete Project management-from conceptualization through product development, regulatory filling to commercialization.- Patent Drafting. - Validation Protocols, Bio-study protocols and other technical reports.- Identifying CRO/CMO.- Coordinating with Drug authorities.