Ennov Dossier

Ennov Dossier is a regulatory submission publishing software designed for life sciences organisations that need to build, manage, publish, validate, and archive regulatory dossiers. Fully integrated with Ennov Doc, Ennov's Enterprise Document Management System (EDMS), it provides a harmonised and seamless solution for submission teams working across multiple departments and global locations. By eliminating fragmented manual processes — such as hunting for correct document versions across file shares or emailing files between team members — Ennov Dossier helps regulatory operations staff meet agency timelines and reduce the risk of missed deadlines.

The platform is 100% web-based, making it ideal for global deployments, and supports a wide range of submission formats including CTD, eCTD, NeeS, VNeeS, and eCopy. Its intuitive drag-and-drop interface allows publishers to link documents into submission assemblies quickly and easily, while built-in validation and pre-configured templates ensure compliant submissions every time.

Core Capabilities

• CTD, eCTD, NeeS, VNeeS, and eCopy format support
• Dossier life cycle management
• eCTD sequence and metadata management
• Robust hyperlinking and bookmarking for navigation assistance during dossier review
• Integrated eCTD validator to ensure compliant submissions
• Built-in submission assembly templates for regions accepting eCTD (e.g. US, EU, GCC, Canada, Swissmedic, TGA) as well as non-eCTD formats, with regular updates as regulatory guidance changes
• Full text and metadata-based searching

Key Features

• Intrinsically connected with Ennov Doc for seamless document management
• Intuitive drag-and-drop user interface for fast submission assembly
• Compatible with any WebDAV-compliant repository
• Automatic compliant PDF rendering
• 100% web-based architecture
• Automated dossier life cycles, workflows, and notifications to eliminate manual processes
• Metadata-based navigation allowing users to locate dossiers by properties rather than filing hierarchy
• Creation of Tables of Contents, hyperlinks, bookmarks, and other navigation aids
• Generation of all required components for compliant submissions, including ICH and regional XML files, correctly named leaf files, and folder structures

Productivity and Compliance Benefits

• Eliminates the need to locate, copy, and upload documents manually for regulatory submissions
• Submission assembly templates can be modified to meet client-specific requirements
• Ennov provides regular template updates in line with evolving regulatory guidance
• Unique metadata-based navigation speeds up dossier and document retrieval
• Automated workflows and notifications reduce reliance on fragmented manual coordination across teams

Deployment and Integration

• Available as cloud-based or on-premises deployment, with the ability to switch between options at any time
• System configuration and management require no IT skills, enabling full user autonomy
• Single-tenancy architecture minimises business interruptions; data can be hosted locally for total flexibility
• ISO 9001 and ISO 27001 certified
• Part of Ennov's broader Regulatory Suite, which includes Ennov Doc for Regulatory, Ennov RIM, Ennov IDMP, DocShifter, and Ennov Artwork

Ennov brings over 25 years of experience serving 450+ life sciences customers, with more than 500,000 users trusting its platform. With 98.5% of projects delivered on time and within budget, Ennov Dossier is a proven solution for organisations seeking to accelerate regulatory approvals and improve operational efficiency across the full product registration lifecycle.