Simplify drug submissions and position your drug for successful health authority review.

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Planning the chemistry, manufacturing and controls (CMC) module for regulatory submissions can be a costly, time-consuming process. A lack of reliable, comprehensive and up-to-date information can lead to approvals taking much longer than planned, resulting in extended timelines and unplanned costs.

Save time and reduce costs while positioning your drug for success with Cortellis CMC Intelligence.™ Eliminate the risk of regulatory delays and rejections with easy access to CMC requirements for more than 130 countries, territories and organizations, all in English, all in one place. The right information at your fingertips when you need it. Reduced time and improved quality translates into meaningful savings – and the ability to redeploy staff to focus on other value-added activities.

Avoid delays in product approvals and successfully bring drugs to market.

Granular information

Avoid delays in product approval and successfully bring a drug to market by building Cortellis CMC Intelligence into your everyday regulatory processes. With Cortellis, you gain access to a granular collection of CMC data requirements for drugs around the world.

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“I really thought it was easy to use, very intuitive … easy for someone who doesn’t go in on a daily [or] weekly basis.”

Director of regulatory affairs,

top 10 global pharma

Local regulatory requirements

Gain visibility to specific CMC requirements for clinical investigation or commercial use as stipulated by official regulations and local practices. This includes low- and middle-income countries and organizations that fund drugs and have their own set of requirements (such as the Global Fund).

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“I liked the content … it was clearly laid out [and] gave information that we needed to do filings in different countries … ”

Senior Manager,

CMC Regulatory Affairs,
mid-size biotech

Verified data

CMC Intelligence provides access to high-quality, comprehensive and verified data for the countries where reliable, up-to-date regulatory information is hard to find. This means your CMC applications will be more accurate and completed  faster and more efficiently the first time – for one country or multiple submissions.

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“I think the product is really nice and easy to use … it’s good to have all the requirements in one place to be able to compare.”

CMC Project Manager

specialty pharma company

Consulting services

Clarivate experts bring together a unique combination of Cortellis content and other available data sources. They provide unrivaled data science expertise, evidence-based consulting, and independent advice across the pharmaceutical R&D value chain. We have the experienced consultants and proprietary methodologies to drive life sciences innovation – faster, with independent objectivity, for better results.

 

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Submit clinical trial and drug registration applications with increased confidence.

Find and efficiently track the latest CMC requirements in countries of interest to ensure compliance with evolving regulations.

Select countries that best fit your needs by understanding specific regional requirements for manufacturing, trials or distribution.

Choose the optimal path to market by pinpointing potential approval pathways.

 

Analyze and develop CMC strategies to balance cost, time, risk and quality.

Fully understand requirements for testing and manufacturing before making partnering decisions.

 

Partner with us.

Our accredited global alliance program delivers value-added solutions by combining offerings from Clarivate with other technology and service providers. Partner with us to drive profitable growth, increase revenue and deliver greater value to your customers.

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Want to learn more?

Contact us to schedule a demo of Cortellis CMC Intelligence.

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