Ennov InSight Publishing
Streamline Your Regulatory Publishing with Ease and Efficiency
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Proven and leading
publishing technology
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Ensure compliance with
regional requirements
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Create, manage and submit
regulatory docs. in any format
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Intuitive user interface &
high user adoption
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Streamline the regulatory
publishing process
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Easily meet deadlines &
maintain 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.
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.
- Accelerates creation of compliant submissions
- Easy drag-and-drop content linking from multiple doc. locations
- Comprehensive paper features for ROW and report publishing
- Smart bookmarking and linking tools
- In-built validation checks for compliance assurance
- User-configurable landing page and favorites function
- Supports global eCTD specifications, including 4.0 and eSubmissions
- Integrated wizards to simplify regional requirements
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
“It’s really nice to work with a software provider that shows a great deal of innovative spirit, has great ambition and is proactive. Above all, I really appreciate Ennov placing particular emphasis on the customer’s user experience.”
Cyrille Jeune,
Regulatory Affairs Systems Manager
Septodont Case Study
“With more than 1500 MAAs in 150 countries, we face a real productivity challenge. With Ennov, we have been able to issue 400 dossier in just 18 months. For the first time, our users are experiencing tremendous time savings when locating documents.”
Aurélie Becquet,
Regulatory Affairs
Regulatory
World-Class Regulatory Content and Information Management
The Ennov Regulatory suite has the power and flexibility to support the entire regulatory product lifecycle from the early planning of registration targets through to product retirement. It is an invaluable solution for regulatory activity planning, product registration management, dossier creation, dossier management and more.
Regulatory
World-Class Regulatory Content And Information Management
The Ennov Regulatory suite has the power and flexibility to support the entire regulatory product lifecycle from the early planning of registration targets through to product retirement. It is an invaluable solution for regulatory activity planning, product registration management, dossier creation, dossier management and more.
Why Choose Ennov
Over 500,000 users trust Ennov
Over 500,000 users trust Ennov
- Over 25 years of experience providing software solutions for Life Sciences and 450+ Life Science customers, with 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
Providing you freedom of choice
- Available as cloud-based or on-premises deployment, you can switch between deployment options at any time.
- System configuration and management require no IT skills, making you fully autonomous
- Improved security and optimized performance. Data can be hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
