Submission Management

The Mission3 OnDemand 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.

Pre-configured submission templates for standard formats (e.g., eCTD, PMA, 510(k)) with the ability to define additional templates for custom assemblies (e.g. for regional affiliates).
Tight linkage with the Document Management platform allows documents to be easily incorporated into submission structures. We provide the flexibility of linking to specific or latest versions of the document or their PDF renditions.
Rich metadata support including grouping countries by region, configuring metadata by country, date fields (e.g., registration date, renewal date, etc.), submission types, etc.
Lifecycle management capabilities to indicate status of submission (in-progress, submitted, etc.).
Ability to configure different user roles with specific rights for content contributors versus reviewers/validators.
Link management tool for addressing any cross-document link errors prior to publishing.
Full support for both electronic as well as paper publishing of submissions using configurable publishing templates with options for volumization, bookmarks, etc., that can be reused across submissions.
Automated creation of an eCTD package, including the XML backbone, folder structures along with published output.
Full support for application sequences and variations, using copy and cloning features.
Integration with GlobalTrack for reporting/tracking of submissions worldwide.