New and emerging submission formats, such as the CTD and eCTD, require a sophisticated approach to managing incremental and
lifecycle-aware submission processes.
From these new regulations come new efficiencies for creating submissions and the potential to re-use the same documents and data in different markets.
This potential is best realized only if you are able to re-use content without spending an inordinate time locating it, determining its status, and determining
how it relates to other regions.
As part of the InSight Suite, Liquent InSight Manager for Assemblies (IMA)
is the first of its kind solution providing a centralized, enterprise-wide view of product details, documents, and submissions to support collaboration,
compliance requirements and the eCTD.
IMA has been designed to ensure the on-time delivery of submissions by providing automated project planning tools. For regulatory groups
or project teams managing a global mix of products, this solution automates much of the project plan for you. This enables you to focus on tracking
progress against the plan.
As the most complete, integrated solution for submission lifecycle management, IMA can help your organization address:
Compliance Risk – Verifying which documentation is in affect with a specific authority
Information Silos – Storing documentation in many different locations and formats can create enormous inefficiencies at approval time
Wasted Effort – Tracking documents and dossiers only to find that either their validity cannot be verified, or they are archived in unusable
formats
Process Bottlenecks – Realizing that an inefficient assembly process can cost valuable weeks when inevitable last-minute changes are
made to submission documentation
Process Changes – Realizing regulatory and business process changes – their impact to technology solutions especially as it relates
to reuse between submission assemblies & global submissions
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