Clarivate Plc 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.
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