EXTEDO's Core Strengths
Broad Format Support
EXTEDO eCTDmanager supports an extensive range of submission formats: eCTD v3, eCTD v4, NeeS, ACTD, eCopy, IMPD, PIP, VNeeS, DMF, ASMF, Clinical Trial Applications, and other regional formats including EAEU. This breadth is particularly valuable for organizations that submit to European health authorities where NeeS and VNeeS formats are still in use alongside eCTD, or for companies operating in regions with unique submission requirements.
Multi-Region Dossier Management
The DOCmanager module enables parent-child dossier management, where a master dossier serves as the source and region-specific child dossiers inherit its content. Changes to the parent automatically cascade to child dossiers, eliminating manual synchronization across regions. For organizations managing dozens of product registrations across many countries, this capability significantly reduces the effort of maintaining multi-region submission portfolios.
Regulatory Agency Adoption
EXTEDO's technology is used by over 35 regulatory agencies worldwide for their own review and validation processes. This agency-side adoption is a significant credibility marker — it means the technology has been evaluated and trusted by the organizations that ultimately receive and review submissions. When the reviewing agency uses similar technology, it also provides some assurance of format compatibility.
SPL Capabilities
For FDA electronic submissions, eCTDmanager includes Structured Product Labelling (SPL) capabilities for data entry and maintenance of product information. SPL authoring is a specialized requirement that not all publishing platforms address.
Validated Cloud Environment
The EXTEDOcloud provides a pre-validated technical environment that is IQ/OQ/PQ validated, supported, backed up, and maintained by EXTEDO's team. The environment is validated under FDA 21 CFR Part 11 and EU GMP Annex 11 Volume 4. Through a shared validation approach, EXTEDOcloud reduces the time and cost of validation for customers.
Where EXTEDO Shows Its Age
EXTEDO's 25-year heritage is both its strength and its limitation. While the platform covers a broad range of regulatory submission needs, several characteristics reflect its legacy architecture:
User Experience
eCTDmanager was designed in a pre-cloud, pre-modern-web era. While EXTEDOpulse brings some modernization, user experience reviews consistently note that the interface requires significant training and doesn't match the responsiveness or intuitiveness of modern SaaS applications. For organizations competing for regulatory talent (a tight market), a modern UI can be a real factor in team productivity and satisfaction.
No Native AI Capabilities
In a market where AI-powered automation is becoming a meaningful differentiator, EXTEDO has not announced native AI capabilities for document classification, automated hyperlinking intelligence, or predictive compliance. Competing platforms are using AI to reduce manual effort in submission assembly — EXTEDO has not yet entered this space.
Architecture Complexity
The product portfolio (eCTDmanager, DOCmanager, RLPmanager, eViewer, eReviewer, EXTEDOpulse, EURS, drugTrack) consists of separate modules and add-ons, each with its own licensing and configuration. While this modularity provides flexibility, it also creates complexity in procurement, deployment, and administration. Organizations often need multiple modules to achieve their full workflow, and the total cost can escalate as modules are added.
Implementation and Consulting Dependency
EXTEDO offers consulting services that are "tailored specifically to the needs of regulatory and related stakeholders" — which is valuable, but also signals that the platform requires professional services to configure effectively. Through workshops, the consulting team establishes business needs, understands processes, and defines the implementation approach. For organizations that want to be self-sufficient quickly, this dependency on vendor consulting can slow time-to-value.
How DnXT Compares to EXTEDO
DnXT Solutions represents a different generation of regulatory publishing technology — cloud-native, AI-powered, and designed for the user experience expectations of 2026. Here's how the two platforms compare:
Architecture
| Dimension | EXTEDO | DnXT |
|---|---|---|
| Foundation | 25+ year codebase, modernized with EXTEDOpulse | Built cloud-native from day one |
| Deployment | Cloud (EXTEDOcloud) or on-premise | Cloud SaaS on Microsoft Azure |
| UI generation | Desktop-era interface with web modernization | Modern responsive web application |
| Module structure | Separate products/add-ons | Integrated platform |
Publishing Capabilities
| Capability | EXTEDO | DnXT |
|---|---|---|
| eCTD publishing | ✓ v3 and v4 | ✓ (v4 in development) |
| NeeS / VNeeS | ✓ | — |
| Automated hyperlinking | ✓ Engine-based | ✓ AI-powered |
| Real-time validation | ✓ Built-in | ✓ Real-time during assembly |
| SPL support | ✓ | ✓ |
| Multi-region dossiers | ✓ DOCmanager module | ✓ |
| Report-level publishing | ✓ RLPmanager module | — |
Collaboration and Review
| Capability | EXTEDO | DnXT |
|---|---|---|
| eCTD viewer | eReviewer (separate) | DnXT Reviewer (integrated) |
| Collaborative annotations | Limited | ✓ Real-time annotations |
| Sponsor-CRO sharing | Secure access available | ✓ Role-based with audit trails |
| Sequence comparison | ✓ | ✓ Side-by-side |
AI and Automation
| Capability | EXTEDO | DnXT |
|---|---|---|
| Document classification | Not available | ✓ AI-powered |
| Intelligent hyperlinking | Rule-based | AI-assisted |
| Compliance prediction | Not available | ✓ |
| Content intelligence | Not available | ✓ |
Integration
| System | EXTEDO | DnXT |
|---|---|---|
| Veeva Vault | ✓ Certified partner | ✓ Native integration |
| SharePoint | Limited | ✓ Direct integration |
| Open APIs | Limited | ✓ REST APIs |
Cost and Implementation
| Factor | EXTEDO | DnXT |
|---|---|---|
| Pricing model | Per-user/module + add-ons | Transparent SaaS subscription |
| Implementation | 1–3 months + consulting | Weeks |
| Consulting dependency | Significant | Minimal |
When EXTEDO Is the Right Choice
EXTEDO remains a strong choice for specific scenarios:
- You need NeeS/VNeeS support: If your submission portfolio includes European national formats alongside eCTD, EXTEDO's broad format coverage is genuinely valuable. DnXT focuses on eCTD and doesn't currently cover NeeS/VNeeS.
- You're a generics company with complex multi-region filings: The DOCmanager parent-child dossier model is well-suited for organizations managing many regional variations of similar products.
- You need on-premise deployment: If your IT security policy requires on-premise software (no cloud), EXTEDO offers that option. DnXT is cloud-only.
- Regulatory agency alignment matters to you: If using the same technology platform as 35+ health authorities provides strategic or credibility value for your organization, EXTEDO has a unique claim here.
When DnXT Is the Better Fit
DnXT is the better choice when:
- Speed matters: You need to start publishing in weeks, not months. DnXT's fastest implementation was under 3 weeks.
- You want AI automation today: Document classification, intelligent hyperlinking, and compliance prediction are built into DnXT now, not on a future roadmap.
- You need strong sponsor-CRO collaboration: DnXT Reviewer was designed for collaborative review workflows with real-time annotations and role-based access.
- You value modern UX: A responsive, intuitive interface reduces training time and improves team productivity.
- You're a biotech or small-mid pharma: DnXT's transparent pricing and rapid implementation are designed for organizations that need enterprise-grade capabilities without enterprise-grade complexity and cost.
- You integrate with Veeva Vault: DnXT's native Vault integration means you can pull documents directly from Veeva and publish without a separate integration project.
Making the Switch
For organizations currently using EXTEDO who are considering alternatives, the transition process is straightforward:
- Export your existing submissions: eCTD packages are standard format — any compliant publishing tool can import the output of another.
- Map your workflows: Identify which EXTEDO modules you use and how DnXT's integrated platform covers those workflows.
- Plan the overlap: Run both systems in parallel for 1–2 submissions to validate the new workflow.
- Leverage DnXT onboarding: The DnXT team provides guided implementation that covers configuration, training, and your first submission.
→ Compare DnXT to your current platform
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DnXT Solutions is a cloud-native regulatory operations platform for life sciences companies. Learn more at dnxtsolutions.com.
About DnXT Solutions
DnXT Solutions provides cloud-native eCTD publishing, review, and regulatory compliance tools for life sciences companies. With 340+ submissions published and 20+ customers, DnXT is the regulatory platform purpose-built for speed and accuracy.
