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Ennov Dossier

Facilitates creation, management, and publishing of regulatory dossiers with features for hyperlinking, validation, and compliance to multiple formats.

Solution by Ennov
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Overview

Ennov Dossier is designed to simplify the creation, management, publishing, validation, and archiving of regulatory dossiers, leveraging the capabilities of Ennov Doc. This platform offers an intuitive and compliant solution for submission publishing, helping organizations meet regulatory timelines and commitments efficiently.

The software addresses the common challenges faced by submission teams, such as the inefficiencies of document sharing and tracking across departments and locations. It reduces the risk of missed deadlines by streamlining document management processes, thus enhancing operational productivity.

Key Features:

  • Drag-and-drop interface for quick document linking into submissions.
  • Automatic dossier life cycle management, workflows, and notifications.
  • Metadata-based navigation for efficient document retrieval.

The tool supports various formats like CTD, eCTD, NeeS, and VNeeS, ensuring compliant submissions for different regions such as the US, EU, GCC, and Canada. Ennov Dossier provides automatically updated submission templates, streamlining the process of creating comprehensive and compliant submissions.

With a fully web-based setup, it allows for global deployment without requiring extensive IT infrastructure. Ennov Dossier integrates seamlessly with Ennov Doc, enabling robust functionality for managing all aspects of a regulatory dossier with increased productivity and compliance assurance.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & Compliance
Target user(s)
QA / Regulatory Affairs
Tag(s)
Quality & Compliance Management