6 months ago
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Enhancements enable pharma, biotech and generics companies to streamline regulatory tracking and optimize life cycle management for small molecules and biologics
LONDON, May 2, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a leading global provider of transformative intelligence, today announced the launch of the newly enhanced Cortellis CMC Intelligence™ solution, featuring a new post-approval variations module. The module for post-approval variations covers regulatory changes across multiple countries, offering meticulously curated requirements to streamline tracking. With this update, pharmaceutical, biotech, and generics companies can effortlessly navigate the regulatory process and prioritize essential actions.
CMC activities account for nearly 18% of the entire R&D budget, emphasizing the importance of optimization and validation. Cortellis CMC Intelligence for post-approval variations enables clients to compare requirements across 64 countries, reducing tracking time and increasing submission rates with organized, timely, and accurate information.
Justin Hubbard, Vice President, Product Management, Life Sciences & Healthcare, Clarivate, said: "This enhancement underscores our commitment to simplifying the complexities of CMC regulatory dossier submissions for our clients. By offering transformative insights, Clarivate accelerates their path to markets and patients. With the ability to efficiently compare regulations across countries for small molecules and biologics, as well as automate CMC regulatory monitoring through user-configured alerts, clients can navigate the process with confidence."
With its new module covering both pre- and post-approval documents, Cortellis CMC Intelligence offers comprehensive lifecycle information for drugs and biologics. Serving as a single-platform solution for CMC requirements, it effectively reduces tracking time and unnecessary costs.
About Cortellis CMC Intelligence
Cortellis CMC Intelligence curates and tracks official CMC regulations and local practices for more than 135+ countries, territories and organizations for small molecules and 64 countries, territories and regions for biologics, with pre-and post-approval module coverage. Robust data is available for 25+ product and regulatory-related filters based on eCTD structure, including 6K+ source documents and over 2K links to Cortellis Regulatory Intelligence, providing access to expanded detail and in-depth summaries from experts in local regulatory practices, paired with reference source documents, to offer a complete picture. The addition of a new post-approval module now makes a comprehensive CMC solution with complete lifecycle information for drugs and biologics to increase submission rates and avoid costly delays. To learn more about Cortellis CMC Intelligence, visit here.
About Clarivate
Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit www.clarivate.com
Media Contact:
Luna Ivkovic
External Communications, Life Sciences & Healthcare
newsroom@clarivate.com
English (United States)