Drug developers face increasing pressures to accelerate the drug development process, including reducing submission timelines. Organizations are answering the challenge by evolving their authoring processes and leveraging technology efficiencies.
For example, lean authoring techniques that incorporate structured content reuse can streamline the creation of complex regulatory documents. Tools that incorporate generative artificial intelligence (AI) can be used to draft initial content from complex data sources.
By automating repetitive tasks and leveraging structured content, regulatory writing processes become more efficient and can lead to increased productivity. Regulatory writers can then focus more on demonstrating their value by aligning the content with key messages, ensuring consistency, and improving the quality of their regulatory documents.
