11 eCTD Publishing Software for Regulatory Publishing

Health Authorities worldwide require pharmaceutical products dossier to be submitted in eCTD format. There are commercially available software for preparation and submission of marketing authorization and clinical documents to different health authorities such as US FDA, MHRA, EMEA, SFDA, TGA and others. These tools are available as both cloud and enterprise version depending on pharmaceutical or biotech companies' requirements. ROS' editorial team has compiled a list of companies that provide software solutions for eCTD publishing.


1. SUBMIT PRO (By Freyr Solution) - Freyr SUBMIT PRO electronic Common Technical Document (eCTD) publishing software eases the eCTD submission process. Designed from the ground up, and with over a decade of experience, it effectively creates, validates, tracks, publishes and manages the entire document life cycle, including complete clinical and pre-clinical research data.

2. eCTD Manager (By Extedo Inc)- eCTDmanager is a scalable, all-in-one submission management software solution that meets the requirements for both electronic submissions, such as eCTD and NeeS, and paper submissions.

3. DocuBridge (By Lorenz)- docuBridge is an advanced electronic submission management and regulatory document management system for compiling, publishing, importing, and reviewing. As an eCTD publishing tool, it is also useful for other regulatory submission formats including (V)NeeS, HTML, PDF and paper. Producing regulatory submissions has never been easier.

4. GlobalSubmit eCTD (By Certara Inc)- GlobalSubmit eCTD software streamlines your regulatory workflows and reduces the number of steps you must perform to arrive at a validated submission, expediting your time to market.

5. PharmaREADY eCTD (By Navitas Lifesciences)- 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.

6. Dossier-Mgmt | SPT (By Educe Solutions)- The Software plays vital role to Create, View + review, Validate,Publish and Manage lifecycle of Submission. Easier and User-friendly interface tonesdown efforts of RA team in preparation, validation and correction activity.

7. Vault RIM eCTD (By Veeva Vault)- Veeva Vault Submissions Publishing incorporates publishing functionality within the Vault RIM Suite to provide end-to-end submission development on a single platform. Employing a continuous publishing process to create, validate, and submit dossiers will dramatically speed your submission delivery.

8. eCTD Solutions (By FDA Basics)- eCTD is a harmonized regulatory filing format widely accepted by several countries. ICH adopted countries have common modules 2,3,4, and 5 and customized administrative module 1 according to country-specific requirements.

9. eCTD Publishing (By Woodley BioReg Ltd)- eCTD submissions enable applicants to submit documents just once. During licence maintenance, only the information that has been changed needs to be submitted, as the assessor is able to view all the information previously submitted.

10. SubmissionExpert (By Amplexor)- SubmissionExpert™ consolidates submission management and publishing capabilities within one unique solution.

11. Mono eCTD Viewer (by LifeCycle Viewer)- Mono eCTD Viewer is available in four editions: BEGINNER, PROFESSIONAL, EXPERT and MASTER. The BEGINNER edition is FREE and has most limitations and none of extra tools. The PROFESSIONAL edition has some features restricted. The EXPERT edition includes most of the features and eCTD lifecycle tools. The MASTER edition has no restrictions and includes ALL the in-depth features and eCTD lifecycle tools.

12. NextGen eCTD - eCTD Global has robust and fully compliant eCTD solution software for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry thought the globe. eCTD Global support all major eCTD accepting countries and for US (United State) dossier/submissions, US (United State) eCTD Suite is fully compliant.


Explore other software available for different regulatory, quality and safety functions by downloading the full report.



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