Accelerating time-to-market with structured content: a new approach for global pharmaceutical companies
The evolving landscape of global pharmaceuticals presents a significant challenge: how to accelerate the time-to-market while maintaining regulatory compliance and content consistency across regions. Adopting structured content solutions offer a transformative approach, enabling companies to manage information more effectively and facilitate faster submissions to regulatory agencies such as the EMA and FDA. At BioTechX in Basel, Chip Gettinger presented how structured content is reshaping pharmaceutical companies’ operations.
Single source of truth for regulatory compliance
At the core of structured content is the concept of a “single source of truth.” This approach ensures that document components and data are stored centrally and can be accessed, updated, and reused across multiple submissions.