Electronic Common Technical Document (eCTD)

PharmaReady eCTD is a web-based electronic submissions ( eSubmissions ) Common Technical Document solution specifically designed for regulatory affairs areas in Health Science organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers.

The FDA is NOW recommending that sponsors wishing to submit applications electronically use the most efficient and internationally agreed to formats recommended in their most recent guidance. The new eCTD guidance differs from the e-NDA and e-ANDA guidance's in one significant aspect: The application table of contents is no longer submitted as a PDF file, but is submitted as an XML file. PharmaReady easily allows you to submit in this new FDA recommended format.

The eCTD standards involve standardized technologies (i.e. XML, Portable Document Format) as well as definitions for file naming, hyper linking, and event font and text color specifications. PharmaReady eCTD is a fully 21 CFR Part 11 compliant eCTD solution based on Microsoft Windows technology. PharmaReady eCTD is designed specifically for the management of submissions using the ICH eCTD standards, technologies and methodologies.

Key PharmaReady eCTD features include:

• Intuitive electronic content assembly processes.
• Integrated document management and publishing features.
• Support for all major regional templates (i.e. EU, US, JP, etc.)
• Submission Life cycle management and consolidated submission reviews.
• Role-based document authoring and access management for multi-user electronic submission, authoring and publishing.
• Produces XML backbone and prepares all Leaf documents for submission to the FDA.
• No user knowledge of XML is required.

Learn more about electronic submissions and how PharmaReady eCTD can easily and seamlessly integrate with PharmaReady DMS, SPL and TRMS.

To view a demonstration of our PharmaReady eCTD product contact@TAKESolutions.com.

• Overview
• Document Management Solution
• Training Records Management
• eCTD Submissions Management
  • eCTD Submissions Templates
• Structured Product Labeling Management