Regulatory Operations Partner,
Not Just a Software Vendor
DnXT combines expert consulting with purpose-built technology. We don't just sell you software — we help you transform how your team manages submissions.
→ Talk to a Regulatory ExpertGet Running in Weeks, Not Months
Our team handles the heavy lifting so your regulatory operations team can focus on submissions, not IT projects.
Platform Setup & SSO
Full platform configuration, single sign-on setup, role-based access control, and Veeva Vault integration. Production-ready in weeks.
Data Migration
Migrate from legacy systems — Documentum, CARA, ISIToolbox, Lorenz — with validated data integrity checks and zero submission downtime.
Training & Change Management
Role-based training programs, hands-on workshops, and ongoing support to ensure adoption across your organization.
Expert Guidance at Every Stage
Our regulatory affairs specialists bring deep domain expertise to every engagement — from submission strategy to post-approval lifecycle.
Submission Strategy & Planning
Develop your regulatory submission strategy, timeline, and resource plan. Align stakeholders and de-risk your path to approval.
eCTD Structure Optimization
Optimize your dossier structure for multi-regional submissions. Minimize rework across FDA, EMA, Health Canada, and 60+ authorities.
Agency-Specific Formatting
Ensure compliance with the latest agency specifications and validation rules. First-time acceptance, every time.
Ongoing Operations Support
For teams that need extra capacity or prefer to outsource submission operations entirely.
Submission Operations Support
Ongoing publishing, validation, and submission support from experienced regulatory operations professionals. Scale up or down as needed.
Publishing as a Service (PaaS)
For companies without in-house publishing teams. We handle the complete submission lifecycle — from document assembly to gateway submission.
Quarterly Technology Reviews
Regular assessments of your regulatory technology stack. Stay ahead of specification changes, optimize workflows, and plan for growth.
Start with a Consultation
Consulting engagements are tailored to your organization's size and needs. Platform licensing scales with your submission volume.
→ Talk to a Regulatory Expert