Cortellis CMC Intelligence

Simplify the drug submission process and increase the chances of an optimal health authority review

Developing a drug is difficult. Going to market shouldn’t be

Cortellis CMC Intelligence is a granular collection of CMC data requirements for small-molecule drugs around the world that can be used to avoid delays?in product approval and successfully bring a drug to market


The expected spend on CMC activities for a company with a $2.9B R&D budget*1


The percentage of first-cycle review rejections due to CMC related issues2


The average cost of a delay in launch per drug, per day3

With Cortellis CMC Intelligence, you can now submit clinical trial and drug registration applications with increased confidence, because whether you need critical information for one country or many, you have things covered.? Cortellis CMC Intelligences gives you easy access to comprehensive CMC-related regulatory requirements for 130+** countries? and organizations, all in English and all in one place, making it easier to:


  • Find the latest CMC requirements – Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations.
  • Compare markets of interest – Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing, trials, or distribution.
  • Map approval pathways – Choose the optimal path to market by pinpointing potential approval pathways.
  • Analyse CMC strategies – Develop CMC strategies to balance cost, time, and quality risk.
  • Determine ideal partners – Fully understand requirements around testing and manufacturing before making decisions around whom to partner with.


Many drug developers have already started to incorporate Cortellis CMC Intelligence into their everyday regulatory processes. To learn how, watch our latest use case videos or request a demo today.


*$2.9B was the average R&D budget for the 17 large and mid-sized companies in CMR
** at final content build

  1. 2018 CMR Factbook from Clarivate Analytics: Drawn from the 2018 R&D Investment Metrics Programme

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Interested in learning more about Cortellis CMC Intelligence and how it can help simplify your drug submission processes?

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