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Navigating the Tech Transformation in Regulatory Operations The world of regulatory operations is undergoing a significant transformation, driven by evolving technology, integrated processes, and changing job roles. This shift presents both challenges and opportunities for organizations in the life sciences industry. The Evolution of Document Management Historically, achieving compliance in document presentation, including bookmarks and […]

Introduction: In the realm of pharmaceutical regulatory affairs, the electronic Common Technical Document (eCTD) has transformed the way drug submissions are prepared and reviewed. eCTD submissions encompass a myriad of information critical for regulatory decision-making, making the review process a complex and meticulous task. To simplify and streamline this endeavor, regulatory agencies and industry professionals […]