Documentum Submissions Manager for eCTD is a product designed for life sciences organizations for managing content submissions. Unbounded Solutions can show you how to utilize Submissions Manager to create, manage, assemble, track and deliver controlled content submissions to government regulatory agencies such as the Food and Drug Authority (FDA). Documentum Submissions Manager for eCTD supports the regulatory submissions process for eCTDs as defined for the exchange of data between pharmaceutical companies and regulatory agencies. Submissions Manager supports US, Europe and Japanese schemas with the US schemas out of box.

Ask the expert consultants at Unbounded Solutions how your organizations and meet regulatory needs by using Documentum Submissions Manager for eCTD. Whilst typical new drug application (NDA) submissions incorporating thousands of pages of content, including clinical study reports, life science companies often experience lengthy approval delays. Currently paper based submissions processes are often labor intensive and do not offer the capability to track changes, serialize a workflow, or provide feedback to the original content creator. The electronic common technical document (eCTD) allows life science companies to transform and automate their submissions process by providing a standard format for US, Europe and Japanese regulatory agencies. The goal of this common standardized format was to reduce the time and resources required to assemble NDA's as well as other standards and initiatives such as Secure Access for Everyone (SAFE), Clinical Data Interchange Standardization Labeling (CDISC), Product Information Management (PIM) and Structured Product Labeling (SPL).

Unbounded Solutions can work with your company to build the infrastructure for creating and assembling electronic submissions while meeting regulatory compliance requirements. All unstructured and structured content that is required for a submission can be tracked and managed through Documentum. Working with Unbounded Solutions, your organization can automate compliance, centralize and manage all workflows for electronic submissions, allow collaboration and thus streamline the review and approval process for new products and reduce the cost and complexity of regulatory submissions.

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