TIMELINE MANAGEMENT STRATEGIES: ENABLING DEVELOPING COUNTRIES TO DELIVER COMPLEX GENERICS TO GLOBAL MARKETS
DOI:
https://doi.org/10.22159/ijap.2026v18i1.53438Keywords:
Complex generics, Developing countries, Timeline management, Pharmaceutical industry, Generic drug development, Project management, Regulatory compliance, Bioequivalence, Organizational culture, Workforce psychologyAbstract
This review analyzes effective project timeline management strategies for complex generic drug development in developing countries, addressing challenges like regulatory inefficiencies, limited infrastructure, and workforce constraints. It provides actionable recommendations to align product development with financial and organizational goals in resource-constrained settings. The paper highlights the growing role of developing countries in the global generics market and examines challenges specific to complex generics. It traces the evolution of timeline management from traditional methods to advanced project management tools, which have reduced development cycle times by 20-30% in adopting organizations. Key factors such as organizational size, workforce psychology, and cultural contexts are analyzed, with strategies to mitigate their impact on timelines. The review emphasizes establishing meaningful milestones, coordinating cross-functional activities, and addressing emerging challenges. It underscores the need to synchronize milestones across organizational, financial, and product factors, adapting lessons from established countries to developing nations. A multifaceted approach integrating regulatory expertise, advanced project management tools, and financial planning is proposed to overcome technical and regulatory hurdles while ensuring financial sustainability and market responsiveness. By adopting these principles, enterprises in developing countries can enhance their ability to supply high-quality generic medicines, improving healthcare accessibility and outcomes. The review aims to equip policymakers and pharmaceutical companies with actionable insights for optimizing development timelines, improving regulatory compliance, and enhancing cross-functional coordination.
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