Submission Management

• Electronic submission is increasingly important for life sciences companies.
• Electronic submission can bring value to the bottom line.

The Mission3 OnDemand 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.

Mission3 OnDemand's 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). Mission3 OnDemand 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 ultimate Program Delivery Platform, increasing business 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.

To complete the submission management and publishing process, Mission3 OnDemand provides full report-level and paper publishing functionality. 510K and PMA submissions are also fully supported.