Our BPM Solution for Dossier Management is a complete package with all the required forms and bundles documents together to send over to the FDA to market a New or Abbreviated New Drug or Biologic for Human Use Approval (NDA).

Configurable and automated business process with deep visibility

The Dossier Management addresses the generation of form FDA-356h_R9 for new drug approval. An NDA application is created which generates form FDA-356h_R9 with additional contents that are selected during the inputs for the application and bundled all together to send over to the FDA as a product for new drug approval under FDA law.

The process assists applicants to generate the forms and helps to compile and track the dossier. The generation of forms automatically with the user inputs improves overall cycle time and provide better accuracy with avoiding the chances of inputting wrong values under wrong section. Also, the validation improves the accuracy of data. Generating the forms automatically also ensures form filing as less of a hassle and more user friendly. Only the authorized group can approve or review the particular application providing even more robustness through the complete process. These workflows provide real-time updates to status into a management dashboard that focuses on overall aging – giving a clear view into the current state at any time.

Key Highlights

Dossier Management in action

  • Dossier-Mgmt-Download
  • Dossier-Mgmt-FDA-Approval
  • DossierMgmt-NDA-Approval-Status-Distribution-Report
  • Dossier-Mgmt-New-Drug-Details

BPM Solution for Dossier Management on Appian AppMarket

Princeton Blue’s BPM Solution for Dossier Management solution has been approved by Appian and is listed on the Appian AppMarket.

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