This study examines the regulatory challenges and organizational strategies in the pharmaceutical industry, focusing on the accelerated approval of first-in-class drugs in International Council for Harmonization (ICH) regions (European Union (EU), United States of America (USA), Japan). The objective is to identify the primary obstacles faced by pharmaceutical organizations in obtaining regulatory approval and to explore effective strategies to navigate these challenges. A quantitative research methodology was employed, utilizing structured surveys distributed to regulatory professionals with direct experience in regulatory submissions for first-in-class drugs. The results indicate that the major challenges include stringent regulatory requirements, complex clinical trial designs, data quality and integrity issues, communication barriers with regulatory agencies, and tight timelines. Significant variability in regulatory requirements was observed across ICH regions, particularly in documentation, approval timelines, and data quality expectations. Effective organizational strategies identified include early engagement with regulatory agencies, leveraging accelerated approval pathways, investing in advanced clinical trial designs, collaborating with external experts, and implementing robust quality management systems. The study finds that while these strategies are generally perceived as effective, their success can vary based on regional regulatory environments and organizational contexts. The study concludes that harmonizing regulatory guidelines across ICH regions, enhancing transparency and communication between regulatory agencies and pharmaceutical companies, expediting review times, and allowing more flexibility in clinical trial requirements are critical for improving the efficiency of the regulatory approval process. These findings offer practical insights for pharmaceutical organizations and policymakers, emphasizing the need for coordinated efforts to streamline regulatory practices and enhance patient access to innovative therapies.