InSight Publishing

Regulatory publishing and submission management for eCTD, NeeS, and paper formats with compliance validation and regional templates.

Solution by Ennov

Overview

Ennov InSight Publishing is a regulatory publishing solution designed for life sciences companies that need to create, manage, and submit regulatory documents efficiently and in compliance with regional requirements. It supports electronic submissions (eCTD and NeeS) as well as paper submissions through a single, common interface, enabling regulatory affairs teams to meet deadlines, maintain data quality, and navigate the complexities of multi-regional submissions with confidence.

Regulatory publishing in the life sciences industry demands meticulous attention to detail, management of multiple formats, and continuous alignment with evolving regional standards. Without an efficient system, organisations face delays, increased costs, compliance risks, and hindered market entry. InSight Publishing addresses these challenges through proven publishing technology, an intuitive user interface, and high user adoption rates.

Core Capabilities

Accelerated creation of compliant regulatory submissions
Global support for eCTD (including eCTD 4.0), NeeS, and paper submissions
Ability to create multiple submissions for different regions from the same assembly
Built-in assembly templates covering all regions to reduce errors and ensure compliance
Integrated wizards for step-by-step guidance through regional requirements
Smart bookmarking and linking tools for easy navigation and organisation of submission documents
User-configurable landing page and favourites function for a personalised experience
Drag-and-drop content linking from multiple document locations

Key Features

Comprehensive and configurable data model
Iterative publishing capabilities
In-built validation tools for eCTD and NeeS submissions, providing comprehensive interactive reports for corrective action
Creation of ICH STF and regional XML files
Management of amendments, supplements, and variations
Common user interface across all submission types
Export functionality for query results
Comprehensive paper features for rest-of-world (ROW) and report publishing

Implementation and Integration

Seamless integration with existing document management systems, including Veeva and Documentum
Drag-and-drop functionality for easy content assignment from multiple document locations
Backed by an expert team with over 100 years of combined experience in regulatory information management
98.5% of projects delivered on time and within budget

Deployment and Compliance

Available as cloud-based or on-premises deployment, with the flexibility to switch between options at any time
100% web-based, highly scalable, and built with a user-centric design
System configuration and management require no IT skills, enabling full organisational autonomy
Single-tenancy architecture minimises business interruptions; data can be hosted locally for total flexibility
ISO 9001 and ISO 27001 certified, ensuring security and quality standards

InSight Publishing is part of Ennov's broader Regulatory Suite, which supports the entire regulatory product lifecycle from early planning through to product retirement. Trusted by over 500,000 users across 450+ life sciences customers, Ennov brings over 25 years of experience delivering software solutions tailored to the needs of the life sciences industry.