Building a Submission Template

Regulatory Administrators define submission templates for a specific regulatory context as defined in the regulatory guidelines for that context and regulatory activity category. You likely need different templates for different regulatory activity categories.

When the regulatory authority releases updated guidelines, the template can be revised to take any changes into consideration.

Before you begin: Configure regulatory contexts, regulatory guidelines, and regulatory calendar templates for Market Registration. See Configuring Market Registration.
  1. Create a submission template. See Creating Submission Templates.
    At this point, the submission template only includes a defined regulatory activity category and is inactive.
  2. Add regulatory contexts. See Regulatory Contexts List.
  3. Add regulatory guidelines. See Regulatory Guidelines List.

    You can only add regulatory guidelines associated with the regulatory contexts.

  4. Add countries. See Countries Page.

    You can only add countries included in the regulatory contexts (by association with the regulatory authority).

  5. Add languages. See Languages List.

    You can only add languages included in the regulatory contexts (by association with the regulatory authority).

  6. Create folders and content.
  7. Define the schedule for all in-house tasks, that is, all tasks required to prepare, review, approve, and deliver the submission dossier. See Schedule for a Submission Project.

    Include all tasks specific to your company. Include tasks to prepare each document required for the dossier, and specify the Volume that the deliverable of that task should be added to. The Volume is used to organize the documents in the dossier.

    You can also add milestones with these milestone purposes to support your process:

    • Dossier Ready
    • Dossier Published
    • Dossier Submitted
    • Dossier Received

  8. Define a checklist for the Dossier Submitted milestone that includes all the items required by the regulatory authority for that regulatory context and regulatory activity category. The checklist helps ensure that all prerequisites for submitting for regulatory approval have been completed. See Working with Checklists for Milestones.
  9. Define a checklist for the Market Authorization milestone that includes all the items required by the regulatory authority to be completed once authorization is received.