Navitas pharmaREADY eCTD is a web-based dossier creation and publishing tool designed to meet the ICH eCTD standard while also allowing for best practice processes to be employed. It meets the requirements in Life Science organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers. The functionality built into the pharmaREADY eCTD product stems from a deep understanding of the requirements for meeting and maintaining compliance with FDA 21 CFR Part 11 and other international standards.
pharmaREADY eCTD is available as an independent product or is easily tightly integrated with other pharmaREADY products including pharmaREADY DMS and pharmaREADY PPS, thereby providing seamless visibility into the entire regulatory document management lifecycle, from document creation all the way to regulatory submissions.
pharmaREADY eCTD is an end-to-end web-based eCTD product providing:
- Submission roadmap / structure creation
- Document assembly
- Work in progress / Final preview
- Internal review
- Sequential / Parallel approval cycles
- Seamless collaboration between all key stake holders of a drug submission including author / assembler, reviewer, approver and publisher.
Key pharmaREADY eCTD features include:
- Intuitive electronic content assembly processes
- Integrated document management and publishing features
- Support for all major regional templates (i.e. US, EU, CA, CH, SFDA, MCC, TGA)
- Submission lifecycle management and consolidated submission reviews
- Role-based document authoring and access management for multi-user electronic submission, authoring and publishing
- Automatic creation of a validated, submission-ready package that includes the index XML backbone, regional XML backbone, and associated Leaf documents
- Module 1 – Regional templates for US, Europe, Canada, Australia, South Africa, Saudi FDA, Swiss Medic readily available – Facilitates easy cloning for other regions
- CTD Module 2 to Module 5 can be independently assembled based on the submission type and module requirements
- Drastically reduce assembly / document-CTD section association time, effort and cost
- Create standardized submission dossiers across different product applications
For more information on eCTD and its benefits, and how pharmaREADY eCTD would add value to your organization, please register for any of our upcoming seminars / webinars. One of our eCTD specialists would be happy to assist you in all your eCTD needs