Electronic Common Technical Document (eCTD)
PharmaReady eCTD product is designed specifically for the management of complex Document and Submission life cycles using the ICH eCTD standards, scalable technologies and process oriented methodologies. PharmaReady eCTD is fully validated, international regulatory compliant software that is 21 CFR Part 11 compliant.
PharmaReady eCTD is available as an independent product and also tightly integrated with other PharmaReady products including PharmaReady DMS and PharmaReady SPL, thereby providing a 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 suite that facilitates
- 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.)
- 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 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 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.
- Pre-built document templates with corresponding CTD sections available - Drastically reduces time taken for eCTD assembly.
- Pre-assembled document templates in appropriate CTD sections enable regulatory affairs personnel to:
- Drastically reduce assembly / document-CTD section association time, effort and cost.
- Create standardized submission dossiers across different product applications.
To view a demonstration of our PharmaReady eCTD product, email us at contact@TAKESolutions.com
International regulatory agencies such as FDA, EMA, Health Canada, etc., are mandating that sponsors wishing to submit drug applications electronically use the most efficient and internationally agreed to formats recommended in their most recent guidance – eCTD (Electronic Common Technical Document).
Adopting eCTD benefits life sciences companies of all sizes, including Life Sciences start ups, by
- Ensuring a shorter submission review lifecycle.
- Dramatically increasing efficiency of communication between the sponsor agency and regulatory authorities.
- Drastically reducing costs compared to paper-based submissions.
- Maximize reusability of data across submissions. eCTD is a harmonized structure that facilitates reusable submission components across different global drug product submissions. Once an eCTD application is created for a specific drug and a specific regulatory agency (e.g., FDA), certain CTD modules can be reused for other regulatory agencies as well (EMA, Health Canada, etc.) with minimal to no changes.
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.