Authors: Sherla Prasanna, B. Swathi
Abstract: By offering reasonably priced substitutes for name-brand drugs, the generic drug market in the United States plays a vital part in guaranteeing accessible healthcare. The U.S. Food and Drug Administration (FDA), through the Abbreviated New Drug Application (ANDA) procedure, is the primary regulatory body that oversees the process of bringing a generic medication to market. In order to help pharmaceutical businesses effectively negotiate the challenging development and approval process for generic pharmaceuticals, this thesis examines project management techniques. In order to provide an organized strategy for cost management, time efficiency, risk reduction, and regulatory compliance, the study incorporates concepts from the Project Management Body of Knowledge (PMBOK), pharmaceutical R&D, regulatory science, and quality systems. Important topics like bioequivalency research, intellectual property issues, risk-based quality management, and cross-functional team communication frameworks are emphasized. The effect of strategic project management on cutting time-to-market without sacrificing quality or compliance is illustrated through real-world case studies and industry best practices.
DOI: http://doi.org/10.5281/zenodo.20441301
