Submission Management

Solution Overview

Planning a submission includes orchestrating all of the deliverables, approvals, resources and timelines for a submission. And every global product has over 10 million regulatory data points. arivis can transfer our experience with a vast variety of submissions.


How We Do It

  • Identify necessary submission components
  • Map documents to appropriate CTD submission sections
  • Plan and manage resources, timelines, and deliverables for submission components
  • Define, interpret, and communicate regulatory submission requirements

 

Submission
Management

Planning a submission includes orchestrating all of the deliverables, approvals, resources and timelines for a submission.... » more

Submission
Publishing

The process of preparing submission content for the electronic submission process is an intricate and precise endeavor.... » more

Submission
Formatting

Preparing documents for submission can be a challenging undertaking.... » more