Powering Consistent, Compliant Content from Core Data to Patient-Facing Formats
Global health authorities are evolving their expectations for how product information is created, reviewed, and distributed. Initiatives such as ePI (electronic Product Information), FDA SPL, and EMA’s DADI aim to replace disconnected document files with modular, metadata-driven content that is accessible, machine-readable, and compliant by design.
Docuvera enables life sciences organizations to transform regulatory labeling and product information into structured, multichannel-ready content—with full traceability across affiliates, submissions, and product variants.
Supporting Standards for the U.S., E.U. & Across the Globe
FDA SPL & HL7 FHIR Compatibility
In the U.S., Structured Product Labeling (SPL) is a foundational format for submitting and maintaining labeling content in XML. Docuvera enables upstream structured authoring that aligns with SPL content architecture:
- Modular components mapped to SPL sections (e.g., Indications, Dosage, Adverse Events)
- Metadata controls to support indexing, labeling history, and safety integration
- Compatibility with downstream SPL tools and publishing systems
As the FDA explores FHIR for labeling interoperability, Docuvera’s structured architecture supports content reuse in FHIR-convertible formats.
Structured Authoring for Labeling Operations
Labeling content must reflect source truth across regulatory, medical, and safety functions. Docuvera allows teams to author, manage, and update:
- Core Data Sheets (CDS/CCDS)
- Package inserts and SmPCs
- Regional and language variants
- HCP and patient-facing versions
Each component is governed, versioned, and metadata-tagged—enabling reuse across markets, channels, and regulatory filings.
ePI (Electronic Product Information) for EU Readiness
The EMA’s electronic Product Information (ePI) initiative is transforming SmPCs and PLs into structured, digitally navigable formats. Docuvera supports ePI readiness through:
- Structured, language-neutral content components
- Regional and product-level variant management
- Multichannel outputs for human-readable and machine-readable formats
- Full traceability across versions and translations
Managing Global Labeling at Scale
For multinational pharmaceutical organizations, managing global labeling involves reconciling:
- Affiliate-level variations
- Product lifecycle changes
- Regulatory and safety updates
Docuvera simplifies this complexity by providing:
- A single source of truth for all structured labeling content
- Role-based access and change control
- Automated impact analysis for updates across global submissions
EMA DADI Integration for Variation Applications
The Digital Application Dataset Integration (DADI) initiative from EMA requires structured datasets to accompany variation forms—replacing free-text entries and document uploads.
Docuvera aligns narrative labeling content with DADI-linked fields through:
- Component-level metadata tagging
- Controlled content branching across product variants and markets
- Structured content that supports synchronization with digital application platforms
Related Standards & Initiatives Supported by Docuvera
| Initiative | Region | Purpose | Docuvera Alignment |
| FDA SPL (Structured Product Labeling) | U.S. | XML-based labeling format for product submissions | Authors modular content compatible with SPL architecture |
| HL7 FHIR for Labeling | U.S. / Global | Enables digital interoperability of health content | Structured content blocks support mapping to FHIR outputs |
| ePI (Electronic Product Information) | EU (EMA) | Digital SmPC and PL formats for patients and HCPs | Enables modular authoring and variant management for machine-readable output |
| DADI | Global | Structured dataset model for variation and submission forms | Metadata-rich content aligns with structured digital application fields |
| Global Labeling Lifecycle Management | Global | Harmonize regulatory labeling across products, regions, and platforms | Provides end-to-end traceability, reuse, and change control |
Business Impact
Organizations using structured content for labeling and product information realize:
- Significant reduction in manual updates across affiliates
- Improved compliance with global regulations (FDA SPL, EMA ePI, DADI)
- Accelerated submission cycles due to modular reuse and version control
- Multichannel readiness across regulatory, digital, and patient access platforms