Clarivate Enhances Cortellis CMC Intelligence with Post-Approval Module to Accelerate Regulatory Success

Rhea-AI Summary

Clarivate Plc (NYSE:CLVT) has launched the enhanced Cortellis CMC Intelligence solution with a post-approval variations module. This update allows pharmaceutical companies to streamline regulatory tracking and optimize life cycle management for small molecules and biologics. The module covers regulatory changes across 64 countries, reducing tracking time and increasing submission rates. Cortellis CMC Intelligence aims to simplify CMC regulatory dossier submissions, automate monitoring through alerts, and offer comprehensive lifecycle information for drugs and biologics.

Positive

• The newly enhanced Cortellis CMC Intelligence solution enables pharmaceutical companies to streamline regulatory tracking and optimize life cycle management.

• The post-approval variations module covers regulatory changes across 64 countries, reducing tracking time and increasing submission rates.

• Cortellis CMC Intelligence offers transformative insights to accelerate clients' path to markets and patients, simplifying the complexities of CMC regulatory dossier submissions.

Negative

• CMC activities account for nearly 18% of the entire R&D budget, emphasizing the importance of optimization and validation, possibly leading to increased costs for companies.

• Although the module covers regulatory changes across multiple countries, there may still be challenges in aligning varying requirements and ensuring compliance.

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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SOURCE Clarivate Plc

FAQ

What is the newly launched module by Clarivate Plc?

Clarivate Plc has launched the Cortellis CMC Intelligence solution with a post-approval variations module.

How many countries' requirements does the post-approval variations module cover?

The post-approval variations module covers regulatory changes across 64 countries.

What percentage of the R&D budget do CMC activities account for?

CMC activities account for nearly 18% of the entire R&D budget.

Who is the Vice President of Product Management, Life Sciences & Healthcare at Clarivate?

Justin Hubbard is the Vice President of Product Management, Life Sciences & Healthcare at Clarivate.