Hybrid Software and Services Model for eCTD Submissions

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Regulatory Publishing is unfortunately not an exact science. Many different factors from different facets of an organization come into play as you prepare your applications for submission. Coordination is a must in organizing and managing the process from start to finish. Using templates to ensure content is written in the proper format, rendering into acceptable PDF documents, compiling them into the appropriate table of contents, and creating the corresponding XML required are just some of the many tasks made easier by software solutions currently available. But what about those “gray” areas, such as the quality assurance of your bookmarks and hyperlinks, or managing the complexity of converting an IND into an NDA? Perhaps your regulatory workload has expanded and resources are unavailable. The workflows needed for successful and timely submissions can be enhanced by incorporating a solution mix which includes both software and servicing options.

Software can quickly make your internal operations automated and run smoothly, but many times, industry expertise is required to complete a task. Having access to a reliable subject matter expert (SME) who can assist with operations can vastly improve both the productivity and quality of your submission by taking advantage of their direct experience. Their out-of-the-box thinking and suggestions can provide insight to your regulatory team that can significantly impact your future approach. Leveraging their knowledge and incorporating best practices gained can help you discover new, more efficient ways to solve problems. This powerful software/service mix can be the boost your organization needs to redirect your internal resources to focus on new and innovative endeavors.

Author: Shawn Nicholas

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