Ennov regulatory suite
Ennov InSight Publishing
Streamline Your Regulatory Publishing with Ease and Efficiency
- Accelerates creation of compliant submissions
- Supports global eCTD specifications, including 4.0 and eSubmissions
- Comprehensive paper features for ROW and report publishing
- Integrated wizards to simplify regional requirements
- Smart bookmarking and linking tools
- In-built validation checks for compliance assurance
- User-configurable landing page and favorites function
- Easy drag-and-drop content linking from multiple document locations
Introduction
Ennov InSight Publishing is a comprehensive solution designed to simplify and streamline the regulatory publishing process. It enables life sciences companies to create, manage, and submit regulatory documents in any regulatory format, ensuring compliance with regional requirements. With advanced tools and an intuitive user interface, InSight Publishing helps organizations meet deadlines and maintain the highest standards of data quality.
The Challenge of Regulatory Publishing
Regulatory publishing in the life sciences industry is a complex and time-consuming task, requiring meticulous attention to detail and compliance with diverse regional standards. Companies often struggle with managing multiple formats, tracking submission lifecycles, and ensuring all documents are up-to-date with the latest regulations. Without an efficient system, these challenges can lead to delays, increased costs, and potential compliance issues, ultimately leading to revenue loss by hindering a product’s market entry and lifecycle management.
Solution Overview: Why Ennov InSight Publishing is Better
Ennov InSight Publishing stands out as a leading solution for regulatory publishing due to its comprehensive functionality and user-friendly design. It supports electronic (eCTD and NeeS) and paper submissions through a common interface, allowing users to create multiple submissions for different regions with ease from the same assembly. The platform’s built-in templates and wizards guide users through the creation process, reducing errors and ensuring compliance with regional standards.
Advanced Tools and User Interface
InSight Publishing offers smart linking and bookmarking tools, making it easy to navigate and organize submission documents. The integrated validation tools ensure that submissions meet the required specifications, providing comprehensive interactive reports for corrective action. The user-configurable landing page and favorites function allow users to personalize their experience, improving efficiency and ease of use.
Implementation and Integration
The platform integrates seamlessly with existing document management systems like Veeva and Documentum and supports drag-and-drop functionality for easy content assignment. The expert team behind InSight Publishing brings over 100 years of experience in regulatory information management, ensuring a successful implementation tailored to your organization’s needs.
Core Capabilities
- Accelerated creation of compliant submissions
- Global for eCTD, NeeS, and paper submissions compliance
- Integrated wizards for step-by-step guidance
- Smart bookmarking and linking tools
- Built-in assembly templates for all regions
- User-configurable landing page and favorites
- Drag-and-drop integration with document management systems
Key Features
- Comprehensive and configurable data model
- Iterative publishing capabilities
- Validation tools for eCTD and NeeS submissions
- Creation of ICH STF and regional XML files
- Manage amendments, supplements, and variations
- Common user interface for all submission types
- Export functionality for query results
Aguettant Case Study
Cyrille JEUNE, Regulatory Affairs Systems Manager
Ennov Regulatory
World-Class Regulatory Content And Information Management
The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning, product registration management, dossier creation, dossier management and more.
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov
Over 20 Years of experience providing software solutions for Life Sciences
250+ life science customers, many more in other industries.
Modern architecture and interface
100% web-based. Highly scalable. User-centric design.
Our commitment to your success
Very high customer satisfaction, 98.5% of projects delivered on time and within budget.
Providing you freedom of choice
Available as cloud-based or on-premises deployment
You can switch between deployment options at any time.
We make you autonomous
System configuration and management require no IT skills.
Improved security and optimized performance
Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
