Accelerate Regulatory Submission Documentation Creation, Review And Approval

Streamlining the regulatory submission process is essential to getting products to market faster today. But you need to create, review and maintain essential submission-related documentation appropriately, even as regulatory rules and requirements vary and evolve by country and region. And if you’ve outsourced to contract research organizations (CROs), your submission process must enable reliable, seamless collaboration with these resources.

Many organizations use a document management system to support these activities, or the process is manual. To what extent can you help people do their jobs more quickly—for example, to instantly find the documents they need? How easily can they collaborate on authoring, and how user-friendly is the authoring environment? How quickly can you make changes to support process improvements? In most cases, even the smallest changes to a system or process can result in weeks or even months of delays.