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Exhibit - Regulatory Compliance

Electronic Submissions  Exhibit

Exhibit - Regulatory ComplianceExhibit - Electronic Submission Software BenefitsExhibit - Electronic Submission Software FeaturesTab - Line

Features

Multiple User Support

Enables multiple users to work on one or more submissions at the same time

Browser-based

Browser based platform independence that is rapidly deployed, easily maintained and can be localized to the working language

Import eCTDs from any eCTD builder

Supports open standards

Simultaneous Document Viewing

Easily verify the integrity of the paper or electronic submission process

Table of Contents (TOC) Creation

Provides easy navigation amongst multiple paper volumes

Tab & Slip Sheets Support

Eliminates the need to manually insert them by integrating them as part of the print files

Volumization

Automates the electronic submission process to ensure paper volume size meets regulatory compliance

Page Stamping

Automates the application of customized visual information (e.g. page numbers, company name and logo’s, …)

Page Scaling

Automatically scales the page to the required size for regulatory compliance (Letter <-> A4)

Page Content Scaling

Maintains original document integrity when scaling page content to provide white space for new information such as headers, footers and cross references

Hyperlink Cross-reference

Automates the addition of cross references on pages to assist navigation through the paper submission

Production Printer Support

Delivers a high-quality, print ready files complete with Xerox DocuTech™ print commands for slip and tab sheets

 
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