Offers a comprehensive overview of regulatory affairs within the pharmaceutical industry, explaining its critical role in drug development, approval, and commercialization. It details the standard and expedited pathways for drug approval by major global regulatory bodies like the FDA and EMA, highlighting how these accelerated programs can reduce time to market. The text also explores the concept of regulatory reliance as an efficiency tool and emphasizes the impact of regulatory timelines on commercial readiness. Finally, it underscores the importance of a strategic regulatory approach and cross-functional collaboration, along with international harmonization efforts to streamline global processes and ensure product safety and efficacy.