Regulatory
By Casey1 author9 articles
- Creating and Managing Categories and Products in the Submission Builder and eCTD ViewerHow to create, rename, and delete categories and products in the Submission Builder and eCTD Viewer. Requires Manager Mode for categories; Editor permissions for products.
- Navigating and Updating Submission Application in the Submission builderThe submission application like NDA, IND are prebuilt in Kivo. A user can add child sections, siblings to the structure. The application c...
- View a document's association with Submissions, eCTDs, and Alias locationsPlease note that user with reader and editor permissions have access to the audit trail of the documents.Here are instructions to access a...
- Importing an eCTD Archive into the eCTD ViewerHow to import a zip archive into the Kivo eCTD Viewer from a document version or via bulk import. Covers format selection, product and application mapping, optional submission linking, and…
- Modifying the name of a SubmissionClick on Submissions Builder Select a category …
- Changing the Name of a Category in Submission BuilderClick on Submission Click on the category to rename Click on the Pencil to enable editing of the name field Change the name Cli...
- Select a Source or PDF in a SubmissionClick on Submissions Select a Category, Product, Application, and submission Select a module The list of Documents in that module a...