Solutions Overview

Mission3's Solutions are designed to provide our customers with a complete Life Sciences product development and compliance landscape. From project planning, collaboration to regulatory electronic submission and integration with your enterprise Mission3 brings structure to a complex industry.

Project Management - Mission3 automates and manages business processes within a product development project. One of its unique features is that it allows the association of documents to a task in the project. This provides the ability to easily locate a document in relation to its process. Further, this feature is the backbone that facilitates dynamic reporting on overall project health. Give partners or customers access to projects in a very secure manner - in fact roles based access can be granted down to a document or task. See project progress from a high-level with executive level reports, or comprehensive project manager reports. Dynamically make decisions based on the information that the system provides in a flexible project management environment. Bring significant control to the entire life sciences development process. If you can imagine the project Mission3 can handle it. Bring thousands of geographically dispersed project contributors together on a decade long project with complete management visibility and regulatory control.

Document Management - Mission3 provides all the rich features of an enterprise document management system. Mission3 supports full library services, check-in, check-out, document locking, metadata, audit trails, and is fully web-based, lowering deployment costs.

Other important features include a rich set of reports for all users, comprehensive search of documents and pathways, elective notification via RSS, QuickLinks to recent documents and pathways, a web-based user interface, and audit trails for every transaction in the system.

Electronic Submission Management - Electronic submission is increasingly important for life sciences companies and should fit into the product lifecycle management ecosystem. Electronic submission can bring value to the bottom line. The Mission3 Electronic Submission Management solution delivers both significant operational efficiency and a tremendous time-to-market advantage. Submissions can be completed with the push of a button instead of months of labor intensive compilation.

Mission3 supports the International Conference on Harmonization (ICH) Electronic Common Technical Document (eCTD) standard which allows life sciences companies to manage their electronic submissions for the FDA, as well as for the European, Canadian, and Japanese regulatory agencies.

FastCrossings web-based interface provides a logical means for controlling specific submission information such as type (NDA, IND, ANDA, etc) and region (US, CA, JP, EU). FastCrossing assembles and delivers valid eCTD XML, and supporting files and folders with the push of a button.

Coupled with the project and document management capabilities, Mission3 creates the "Organized Enterprise", increasing shareholder value in a virtual, dynamic environment.

Mission3 also facilitates linking of documents at any version in order to compile submissions while documents are still being processed. This enables the submission to be ready when all work is done.

Built-in validation regulates the assembly of submissions to ensure that only valid structures are output. Standards compliance - Mission3 fully supports eCTD lifecycle management and is capable of producing initial submissions, supplements, amendments, and variations.

Reuse - To create any derivative submissions, for instance to create a regional submission, Mission3 provides cloning. Cloning allows users to select for editing only those parts of a submission that they need to change, allowing the remainder to inherit changes from the original.

Link Management - Mission3 further enhances your efficiency by providing comprehensive cross-document link management, ensuring links are always correct, automatically.