DNXT Solutions is a software and consulting company focused on regulatory operations for life sciences.

Our platform — DNXT Publisher Suite — handles eCTD submission assembly, document validation, and regulatory publishing  for Pharma, biotech, and CRO organizations. From dossier planning to agency submission, teams use a single platform instead of stitching together manual processes and legacy tools.

Our consulting team brings hands-on experience in regulatory operations, system implementation, and end-to-end delivery across R&D and commercial functions. We work with organizations to assess, optimize, and modernize their regulatory technology and processes.

 What we focus on:

  - AI-Assisted Document Preparation: Automated link creation, bookmark generation, and cross-reference validation to reduce the manual work that often leads to technical deficiencies.

  - Multi-Regional Support: Publish to FDA, EMA, Health Canada, TGA, and other agencies from one platform. eCTD 3.x and 4.0 supported.

  - Compliance & Security: 21 CFR Part 11 compliant. Full audit trail on every action.

  - CRO-Ready Architecture: Multi-tenant design with data isolation so CROs can manage multiple sponsors from a single instance.

  - Consulting Services: Regulatory operations strategy, system implementation, process optimization, and technology advisory for life sciences organizations.

Our customers have seen meaningful improvements in submission prep time, first-time acceptance rates, and audit readiness. Implementation typically takes 4-12 weeks.

We integrate with Veeva Vault, SharePoint, Box, Documentum, Okta, Azure AD, and other systems commonly used in regulatory workflows.

  Learn more: https://www.dnxtsolutions.com

DnXT Solutions

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