Ennov regulatory suite
Ennov InSight Registration
Transform Your Regulatory Data into Valuable Insights
- End-to-end regulatory information management
- Streamlined dossier planning and submission tracking
- Comprehensive product and registration management
- Integration with Microsoft Power BI for advanced analytics
- 100% web-based, scalable solution
- Supports global regulatory compliance requirements
- Enhanced data security and user-friendly interface
Introduction
Ennov InSight Registration is an advanced solution, honed from 20 years of customer feedback, designed to revolutionize regulatory information management (RIM). It empowers organizations to efficiently manage, analyze, and utilize their regulatory data, ensuring compliance while unlocking valuable insights. With Ennov InSight Registration, companies can streamline their regulatory processes, reduce time from study completion to submission, and ultimately accelerate the approval of new treatments to improve patient lives.
The Challenge of Regulatory Information Management
Regulatory compliance in the life sciences industry involves handling massive quantities of data, which can be overwhelming and time-consuming. Organizations face the challenge of maintaining compliance while managing extensive regulatory content, tracking submissions, and ensuring timely and accurate information processing. Without a robust RIM system, these challenges can lead to noncompliance, inefficiencies, increased costs, and revenue loss from delays in getting treatments to market. The complexity of regulatory requirements and the need for seamless data integration further exacerbate these issues, making it crucial for organizations to adopt a comprehensive RIM solution.
Solution Overview
Ennov InSight Registration addresses these challenges by providing an end-to-end RIM platform that simplifies and streamlines regulatory processes. Its robust data management structure supports the entire regulatory lifecycle, from dossier planning and submission management to product and registration tracking. The platform’s integration with Microsoft Power BI offers advanced analytics and reporting capabilities, enabling organizations to derive actionable insights from their regulatory data. Additionally, flexible APIs make Ennov InSight Registration a central part of your regulatory ecosystem, allowing for seamless integration with other systems. Ennov InSight Registration’s web-based interface, with well-loved user-friendly features, ensures ease of use and accessibility, while its design meets the needs of companies of all sizes, from startups to multinational corporations.
Core Capabilities
- End-to-end regulatory information management
- Dossier planning and submission tracking
- Comprehensive product and registration management
- Integration with Microsoft Power BI for advanced analytics
- Workflow automation and process efficiency
- Secure, web-based platform
Key Features
- Centralized regulatory data repository
- Seamless integration with existing content management systems
- Intuitive user interface for ease of use
- Comprehensive and configurable data model
- Real-time analytics and reporting dashboards
- Compliance with global regulatory standards
- Scalable to meet organizational needs
Ennov Regulatory
世界最高水準の規制コンテンツと情報管理
Ennov Regulatory Suite は Ennov Doc、Ennov Dossier、Ennov Process の機能と柔軟性を組み合わせ、登録目標の初期計画から製品の廃止まで、規制当局の製品ライフサイクル全体にわたってサポートするものです。Ennov Regulatory Suiteは、規制当局の活動計画、製品登録管理、資料作成、資料管理などにおいて非常に有用なツールです。
Ennovを選ぶ理由
Ennovを信頼する数百社の顧客企業
20年以上にわたるライフサイエンス分野におけるソフトウェアソリューションの提供経験
ライフサイエンス分野の顧客は250社以上、その他の業界も多数
最新のアーキテクチャとインタフェース
WEBベース100％. 高い拡張性. ユーザー重視の設計
お客様の成功のために
顧客満足度が非常に高く、98.5%のプロジェクトが期限内、予算内に納品されている
お客様の選択の自由を尊重
クラウドベースまたはオンプレミスでの導入が可能
配置オプションの切り替えはいつでも可能
お客様の自主性を尊重
システム構成および管理に関するITスキルは不要
セキュリティの向上とパフォーマンスの最適化
データはローカルに保存されるが、柔軟性に富む。シングルテナントであるため、業務の中断を最小限に抑えられる
クラウドベースまたはオンプレミス
マルチプラットフォーム
