EURSnext

EXTEDO EURSnext is an eCTD and NeeS validation and reviewing solution designed for regulatory agencies. It supports the end-to-end assessment of electronic submissions, and is used by over 35 authorities worldwide, including the EMA. The tool is intended to help agencies manage increasing volumes of submission documents, avoid backlogs, and ensure that medicinal products meet regulatory requirements within procedural timelines.

The solution addresses common challenges faced by agency reviewers, including time pressure on assessment timelines, high submission volumes, difficulty tracking changes across a product's lifecycle, fragmented document storage across multiple data silos, and the need for smarter automation within complex IT infrastructures.

Core Capabilities

• Navigation of submission structures across different view modes for efficient handling
• Search, view, and annotation of imported submissions through the interface
• Filtering and organisation of submissions based on criteria such as regulatory activities and the overall regulatory status of a drug product
• Export of annotations to support the creation of assessment reports
• Quick access to submissions throughout the entire lifecycle of a medicinal product
• In-built technical validation against the latest validation criteria provided by regulatory authorities

User Interface and Access

• Fully browser-based reviewing system requiring no client software installation
• User-friendly and intuitive interface with integrated, context-sensitive online help
• Supports collaborative working between agency staff and external assessors
• Designed to minimise the need for structured training sessions
• Scalable to support distributed workforces with many hundreds of users

Deployment and Integration

• Can be installed and validated within a matter of days depending on system specifications
• Provides an API for integration with third-party systems to connect with existing processes
• Includes an integrated connector that automatically synchronises a local agency repository, or partial repository, with the EMA Common Repository
• Scalable for numerous internal and external users where IT resources may be limited

Available Supporting Services

• Business Process and Regulatory Consulting: Workshop-based consulting to establish business needs, understand existing processes, and define appropriate implementation approaches for eCTD submissions
• Education and Training: Tailored training sessions covering technical and regulatory topics, delivered either in-house or onsite
• Technical Consulting: Support for correct installation, implementation, and integration of the solution within an organisation

EXTEDO EURSnext is part of the broader EXTEDOpulse platform, which covers document management, registration management, submission management, safety management, and quality management. EXTEDO has provided regulatory information management solutions to both industry and agencies for over 25 years.