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
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