Supporting Harmonized Submissions, Shared Reviews, and Postmarket Safety at Scale
As regulators pursue more collaborative and transparent review models, pharmaceutical companies must deliver consistent, traceable content across geographies and product lifecycles. Programs like Project Orbis, Access Consortium, and Sentinel demand modular documentation, variant control, and structured safety content that can support both review and postmarket surveillance across multiple authorities.
Docuvera enables global teams to manage labeling, safety, and clinical content as structured components—supporting international harmonization without reauthoring or losing regulatory traceability.
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
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
| Initiative | Region | Purpose | Docuvera Alignment |
| Project Orbis | Global (FDA-led) | Parallel regulatory review of oncology submissions | Structured authoring and regional variant management for aligned submissions |
| Access Consortium | Global | Multi-agency collaboration on reviews and decisions | Modular content reuse with traceable regional adaptations |
| FDA Sentinel | U.S. | Structured safety data for signal detection and monitoring | Enables consistent, versioned safety messaging across channels |
| Global Lifecycle Labeling & Safety | Global | Maintain content consistency across countries and updates | 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