Clarivate Plc, a global leader in transformative intelligence solutions, has announced the launch of the upgraded Cortellis CMC Intelligence™ solution, featuring an innovative post-approval variations module. This latest enhancement is designed to empower pharmaceutical, biotech, and generics companies to streamline regulatory tracking and optimize life cycle management for small molecules and biologics.
The Cortellis CMC Intelligence platform has been augmented with a new post-approval variations module, which meticulously tracks regulatory changes across 64 countries. By providing curated insights into post-approval requirements, the module facilitates efficient tracking and enables companies to prioritize critical actions with confidence.
In an industry where CMC activities consume a substantial portion of the R&D budget, optimizing and validating regulatory processes is paramount. The introduction of Cortellis CMC Intelligence for post-approval variations underscores Clarivate's commitment to delivering solutions that drive operational efficiency and regulatory compliance.
By offering comprehensive lifecycle information for both pre- and post-approval documents, Cortellis CMC Intelligence serves as a unified platform for managing CMC requirements. This consolidation of critical information not only reduces tracking time but also minimizes unnecessary costs associated with regulatory compliance.
With the launch of the enhanced Cortellis CMC Intelligence solution, Clarivate continues to uphold its reputation as a trusted partner for organizations seeking to optimize their regulatory processes and accelerate the delivery of life-saving therapies to patients worldwide.
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