The FORM 2253 Generation integration by Aprimo automates the production of FDA-compliant submission packages for life sciences organizations. This tool maps DAM metadata directly to official forms to bundle approved marketing assets with the required regulatory documentation. By streamlining this process, companies ensure data integrity and significantly reduce the manual administrative burden of regulatory filings.
What it Does
The FORM 2253 Generation integration streamlines the regulatory submission process for life sciences and pharmaceutical organizations. By leveraging data already stored within Aprimo, this integration automates the creation of the FDA 2253 form package. It ensures that the required forms and the associated marketing materials are bundled together accurately, reducing manual entry errors and accelerating the time-to-submission for promotional materials.
How It Works
The integration operates through a four-stage process: first, assets and metadata are finalized in the Aprimo DAM. Upon approval, the integration triggers a data extraction service that maps Aprimo metadata fields to the corresponding sections of the FDA 2253 form. The system then generates the PDF form and bundles it with the original asset and any supporting files. This unified package is stored in a designated area for the regulatory team to download for final FDA submission.
Key Capabilities
- The FORM 2253 Generation integration streamlines the regulatory submission process for life sciences and pharmaceutical organizations
- By leveraging data already stored within Aprimo, this integration automates the creation of the FDA 2253 form package
- It ensures that the required forms and the associated marketing materials are bundled together accurately, reducing manual entry errors and accelerating the time-to-submission for promotional materials