Cortellis CMC Regulatory Intelligence

Empowering the entire drug development journey

Achieve successful regulatory submissions on your first attempt. Experience unrivalled access to both pre and post approval CMC documentation.

Simplifying access to regional governance

Simplify access to regional governance and reduce research time with a single source of global chemistry, manufacturing and controls (CMC) requirements.

Reducing the risk of delays and rejections

Reduce the risk of regulatory delays and rejections with easy access to CMC requirements for multiple submission types and pharmaceutical forms for more than 130 countries, territories and organizations.

How we help

Ensure compliance with regional regulations

Find and efficiently track official regulations, regional requirements and local practices for manufacturing, trials or distribution in select countries that best fit your needs for pre and post approval variations.

Understand requirements for clinical investigation or commercial use

Gain visibility into specific CMC requirements for clinical investigation or commercial use with dedicated modules covering small molecule and biologic-specific requirements, for both pre and post approval stages.

Avoid delays in product approvals and successfully bring drugs to market

Confidently prepare CMC regulatory dossiers and submit clinical trial and drug registration applications accurately and more efficiently the first time – for one country or multiple submissions, now with end-to-end CMC documents coverage.

Why choose us

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Verified source data

High-quality, comprehensive and verified data for countries where reliable, up-to-date regulatory information may be hard to find.
Organized according to ICH eCTD format, with direct links to source documents
2700+ source documents with citations

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Curated by CMC experts with 10+ years of industry experience

Now with complete lifecycle information for drugs and biologics with the new module, covering both pre- and post-approval documents

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Detailed country reports and requirement tables

Detailed country reports with visual regulatory pathways, as well as Summary and detailed requirement comparison tables of local regulatory practices and reference documents.

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Granular detail

Granular collection of global CMC data requirements for small molecules and biologics

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Daily updates and email alerts

Daily updates based on new and changing requirements as released by global regulators. Setting email alerts to be notified on content changes is also a possibility.

Want to learn more?

Speak to our team 3p

34+

applied product- and regulatory-related indices

25+

product and regulatory-related filters based on eCTD structure

170+

links to Cortellis Regulatory Intelligence for access to expanded detail

135+

countries, territories and organizations for small molecules covered in the reports

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countries, territories and regions for biologics covered in the reports

With Cortellis CMC Intelligence it’s easy for me to know which information is correct and have the reference for it.

International Regulatory Affairs Manager International non-government organization (NGO)

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

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

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Cortellis CMC Intelligence