Liquent Regulatory Solutions for Life Sciences

Home > Solutions > Regulatory Software > Product Registration Management > IMR: Overview

Overview > Features & Benefits > Technical Specification

As part of the InSight Suite , InSight Manager for Registrations (IMR) provides a centralized, global view of product details and submissions making it easy for you to maintain marketing authorization details on all current and planned products including manufacturing and labeling details, commitments, licenses and registration status.

Users benefit from a single repository that provides a centralized view of your product portfolio, with the ability to drill down to the property level through simple queries and reports. IMR proactively steps you through the process of updating your registrations so that you can confidently and consistently answer the following questions for every product registered or pending registration:

Which licences are due for renewal?
What are the ramifications of changing a supplier?
What information must I submit in response to a new regulation or change?
How can I quickly find information to respond to a specific agency enquiry?
Have I satisfied all the requirements to bring my product to market?
Are my processes compliant today?
Does everyone in my company know what is registered and where?
What have affiliates told me about plans or status?

As the most complete, integrated solution for registration management, IMR can help your organization:

• Monitor market approvals against target dates to ensure that marketing launches (and projected revenue) are on schedule
• Provide and track product or submission specific correspondence
• Identify maintenance tasks associated with a product, submission or correspondence
• Perform impact analysis of proposed or actual product detail changes to determine affect on products and notification requirements
• Automatically identify needed submission instances when product changes warrant
• Maintain compliance as product, market and regulatory conditions change

Customers interested in IMR are also interested in:

• Document Management: Enhancing document creation, management and control
• Submission Management: Delivering lifecycle aware publishing
• Lifecycle Management: Complete submission lifecycle planning and tracking to increase efficiencies and support new submission standards
• Information Products: IDRAC’s regulatory intelligence solutions
• Professional Services: Full spectrum support from Liquent’s regulatory and submission experts