Build Modern Submissions with Modular, Metadata-Rich Content

Regulatory submissions are no longer static, document-bound packages. With the global shift to eCTD 4.0 and modernization initiatives like FDA KASA and EU DADI, health authorities now expect structured, traceable, and componentized content that supports lifecycle management and system interoperability.

Docuvera enables structured content operations that match the complexity of today’s global submission models—without relying on manual rework or disconnected documents.

Supporting Standards for the U.S., E.U. & Across the Globe

Structured Authoring for eCTD 4.0 Readiness

eCTD 4.0 introduces more granular lifecycle control, two-way communication, and metadata-driven content placement. Docuvera allows teams to create, version, and reuse content components that map directly to eCTD modules and subsections.

  • Modular content aligned to Modules 1–5
  • Metadata tagging at the component level (e.g., indication, region, document type)
  • Audit-ready versioning and change history
  • Integration-ready for eCTD publishing tools (e.g., Extedo, Lorenz, Veeva Vault Submissions)

KASA-Ready CMC Documentation

FDA’s Knowledge-Aided Assessment and Structured Application (KASA) framework transforms how CDER reviews CMC content, relying on structured data to inform risk-based assessments and reduce subjectivity.

Docuvera supports structured authoring for critical Module 3 elements:

  • Control strategy
  • Specifications and analytical methods
  • Formulation and manufacturing overviews
  • Consistency across supplements, variations, and global dossiers

Structure-Data File (SD File) Support

The FDA encourages the use of Structure-Data Files in ANDA submissions to improve the consistency and machine-readability of key CMC data. Docuvera enables upstream alignment by ensuring that textual descriptions of chemistry, manufacturing, and quality elements are authored as structured, labeled components—ready to feed downstream tools and formats.

Modular Content for RIM & Gateway Integration

Docuvera prepares content for seamless ingestion into:

  • RIM systems such as Veeva Vault RIM
  • eCTD publishing platforms including Extedo, Lorenz, and others
  • Regulatory gateways through HL7, XML, or API-based interoperability

Unlike document-based systems, Docuvera allows metadata and component structure to flow across platforms, improving coordination across Regulatory Affairs, Quality, and Publishing teams.

Lifecycle Management Without Duplication

As submissions evolve, so do the expectations for managing overlapping, reused, and modified content. Docuvera enables:

  • Single-source updates across original, renewal, and variation sequences
  • Controlled branching of regional or product-line variants
  • Centralized governance across the entire submission lifecycle

Teams spend less time tracking changes and more time delivering accurate, compliant content.

Related Standards & Initiatives Supported by Docuvera

Initiative Region Purpose Docuvera Alignment
eCTD 4.0 Global / U.S. Modular, metadata-rich content for regulatory submissions Supports authoring of content components with full traceability and lifecycle metadata
KASA (FDA CDER) U.S. Structured CMC data for AI-driven quality review Enables structured authoring of Module 3 elements with metadata tagging
SD Files U.S. (FDA) Structured data files for chemistry/manufacturing details Prepares structured narrative components to align with SD File expectations
RIM Modernization Global Transition to structured interoperable content in RIM systems Provides upstream content governance and metadata integration for RIM platforms
eCTD TRC 4.0 U.S. Technical validation of eCTD files to prevent rejections Ensures structured content is properly tagged and formatted for downstream systems.

Business Impact

Organizations that implement structured content authoring for regulated submissions typically realize

  • 30–50% time savings in submission preparation and QA
  • Significant reduction in manual reconciliation of reused content
  • Improved consistency and audit readiness across submission histories
  • Faster health authority responses through better alignment with digital review tools
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