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