Our full suite of regulatory solutions and services prepares you to effectively manage submissions for the updated format.
DXC built the first Electronic Common Technical Document (eCTD) submission tool on the market. As global health authorities prepare for eCTD 4.0 implementation — with the US targeted for 2029 — DXC offers the expertise and solutions needed to ensure a seamless, compliant transition.
DXC is leading the transition to eCTD 4.0 with deep expertise, proven technology and a future-ready approach. We will help simplify the challenges and complexities that your organization encounters with our experienced support staff and proven reliability. Embrace our knowledge, so that you can get a jumpstart on meeting regional timelines. Don’t wait for the deadline. Let us help you prepare today.
eCTD v4.0 is based on the HL7 Regulated Product Submission (RPS) standard, which supports global harmonization and is intended to be more adaptable across different regions and authorities, including potential integrations with AI/ML tools.
The eCTD 4.0 version addresses several limitations of the previous version (eCTD v3.2.2) and brings improvements that align with modern regulatory and technological requirements.
Built for versatility, the structure supports regulatory submissions for all product categories — ranging from drugs and medical devices to cosmetics, veterinary products, food additives and more.
Upcoming Voluntary and Mandatory eCTD 4.0 Timelines
Global Health Authorities are setting clear deadlines for implementation. Staying proactive will position you favorably as these deadlines approach.
Learn more about eCTD 4.0 from the International Council for Harmonisation and The FDA.
DXC offers a full suite of regulatory submission solutions, services and expertise to support your transition.
Publishing and lifecycle management capabilities are available in our Regulatory business automation software and services. DXC Technology stands at the forefront of innovation, leading the industry in implementing the new eCTD 4.0 format.
Submission readiness and project management is supported by an experienced and long-tenured staff of publishers, submission managers and regulatory operations subject matter experts. They're prepared to help your team manage the increased complexity introduced by eCTD 4.0.
DXC can be flexible about how clients can integrate our software and services using plug-ins to their specific systems. We can work with you on existing workflows by supporting hybrid environments where eCTD 3.x and eCTD 4.0 submissions are managed in parallel during transition periods.
As organizations prepare for eCTD 4.0 transition, our flexible service models can be tailored to support clients’ needs, and increase cost efficiency with options including blended pricing models that leverage offshore centers to allow 20-30% savings versus internal operations. Cost savings are increased by eliminating the need to maintain large internal groups to handle spikes in work.
As the standardized format for submitting regulatory applications that include clinical trial data, eCTD is directly tied to the drug development work performed by this multinational pharmaceutical organization, which leveraged DXC's AI-enabled intelligent solutions to solve operational and technological challenges around clinical research.
Catch up to the current state of AI adoption in regulatory affairs in this report, where we document the tools, applications and governance considerations that define the transition from a paper-based to an intelligence-augmented regulatory ecosystem.
Anthony Szaro
Global Head, DXC Life Sciences Regulatory Business Process Services
Jamie Labiak
Regulatory Engagement Manager, DXC Life Sciences Business Process Outsourcing
See the table below for details on the differences between 4.0 and 3.x:
Organizations undertaking the transition will face the following:
Transitioning to eCTD 4.0 demands more than just technology — it requires a trusted partner with deep expertise and a forward-thinking approach. With decades of experience, proven solutions, and a commitment to innovation, DXC simplifies the complex, accelerates compliance and turns transformation into opportunity.
DXC recommends following these best practices to ready your business for regulatory authorities' requirements and submission success:
