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Why Docuvera > Current/Future Standards

Structured Submissions & Lifecycle Management

eCDT 4.0 – KASA – DADI – SD File

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.

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

Project Orbis & Parallel Review Enablement

Project Orbis, led by the FDA Oncology Center of Excellence, supports concurrent submission and review of oncology products by regulators in the U.S., Canada, Australia, Singapore, Switzerland, Brazil, and the UK.

Docuvera supports Orbis-ready documentation through:

Modular authoring of clinical, labeling, and safety content
Controlled variant management by region, agency, or indication
Full traceability across submission packages and updates
Structured metadata for reuse across submissions and platforms

Access Consortium & Multi-Agency Collaboration

The Access Consortium (comprising Health Canada, TGA, Swissmedic, HSA, and MHRA) promotes shared regulatory assessments and aligned decisions.

Docuvera supports content strategies that match this model:

Centralized governance of high-value documents (e.g., CCDS, IBs, safety summaries)
Regional content branching with audit trails for local requirements
Structured authoring that supports XML-based or digitally tagged components

Project Orbis & Parallel Review Enablement

Postmarket Safety Content Aligned with Sentinel
The FDA Sentinel Initiative and similar safety monitoring systems depend on consistent, structured product information that supports signal detection, labeling updates, and real-world data linkages.

Docuvera enables:

Aligned safety messaging across medical information, labeling, and regulatory responses
Modular update of adverse events, contraindications, and risk language
Version control to track what safety content was in force at each point in time
Authoring environments that support real-time responses to emerging safety findings

Multinational Product Management at Scale

Global content collaboration requires more than translation—it requires architecture.

Docuvera enables multinational teams to:

Maintain a governed global content core
Manage branching logic for country-specific data, references, and languages
Ensure reuse and alignment across submission types, formats, and agencies
Reduce duplication without compromising local compliance

Related Standards & Initiatives Supported by Docuvera

Project Orbis

Region

Global (FDA-led)

Purpose

Parallel regulatory review of oncology submissions

Docuvera Alignment

Structured authoring and regional variant management for aligned submissions

Access Consortium

Region

Global

Purpose

Multi-agency collaboration on reviews and decisions

Docuvera Alignment

Modular content reuse with traceable regional adaptations

FDA Sentinel

Region

Global

Purpose

Structured safety data for signal detection and monitoring

Docuvera Alignment

Enables consistent, versioned safety messaging across channels

Global Lifecycle Labeling & Safety

Region

Global

Purpose

Maintain content consistency across countries and updates

Docuvera Alignment

Component-level governance, reuse, and audit-ready content structure

Business Impact

Pharmaceutical companies operating globally achieve:

Reduced duplication and faster turnaround across regulatory regions
Stronger consistency and traceability in safety and labeling updates
More efficient participation in global review models (Orbis, Access)
Improved pharmacovigilance readiness through structured, linked safety messaging

Related Content:

Digital Transformation
Regulatory Compliance & Risk Mitigation
Enterprise Governance

Docuvera is here to help you succeed—compliantly, efficiently, and confidently.

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