The Dossier Management accelerator enables Life Sciences companies to generate and manage entire package with all the required forms and bundle of documents to be sent over to the FDA to market a New or Abbreviated New Drug for Human Use Approval.

Create your own Dossier Management solution using this accelerator.

Accelerator Overview

The Dossier Management accelerator 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 accelerator 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 provides better accuracy with avoiding the chances of inputting wrong values under the wrong section. Also, 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 of the current state at any time.


Key Highlights

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