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

Key Features

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
Case Study

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.

Regulatory Documents

Unified Access to All Documents for Improved Productivity and Efficiency

Dossier Publishing

Manage Regulatory Submissions and Publish to Any Output Format

IDMP

Simplify IDMP Management with Ensured Readiness and Increased Data Quality

RIM

A Single Authoritative Source of Regulatory Information

ARTWORK

Ennov regulatory suite Ennov Artwork Artwork Management Software

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 industries

Cloud-based or On Premises

multiplatform

Multi-Platform

iso 2015 ready

ISO 9001:2015 certified