Investigational New Drug (IND) Product Registration

The Product Registration solution addresses the generation of form 1571 for the registration of a new drug application. A new drug application is created which generates form 1571 with additional content that is selected during the application process and bundled together to send over to the FDA as a product for registering the drug under FDA law.

In addition, the solution also addresses actions that can be taken on a particular registration that was already submitted to FDA.

Key Application Highlights:

  • Cycle-times are vastly improved via systematic workflow
  • Accurate auto-generated PDF forms from Appian forms
  • Easy-to-use templates for user completion
  • Comprehensive view for users to access information on application and application changes
  • Generation of reports for all applications with filters
  • Role-based visibility of milestones across the organization