Smart Builder takes the pain out of US FDA and Brazil Registro submissions and EU technical file documentation with software that walks you through each step of the process. Advance through every section with guidance on what each field should contain. The progress bar provides an at-a-glance snapshot of how far along you are.
Key textual components like the product name and Indications for Use can be recorded as smart phrases to ensure that they remain absolutely consistent; any edits you make to such a phrase will automatically be applied throughout the document.
This headache-free system for building and maintaining your documentation helps you avoid errors and inconsistencies that risk delaying or jeopardizing your market access.
To access Smart Builder
- Click "Smart Builder" under Premium Services on the Navigation Bar
Note: User manuals related to the specific Smart Builder electronic templates can be located within the specific project.