BIOPHARMA INTELLIGENCE | DISCOVERY, CLINICAL & REGULATORY

Cortellis CMC Intelligence

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

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Ensure successful filings the first time around.

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

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

  1. 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.
  2. 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.
  3. 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.

Why choose us

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
  • Curated by CMC experts with 10+ years of industry experience
  • 2700+ source documents with citations

Detailed country reports and requirement tables

  • Detailed country reports with visual regulatory pathways
  • Summary and detailed requirement comparison tables of local regulatory practices and reference documents
  • Covers 135+ countries, territories and organizations for small molecules and 64 countries, territories and regions for biologics

Granular detail

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

Daily updates and email alerts

  • Daily updates based on new and changing requirements as released by global regulators
  • Set email alerts to be notified on content changes

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Want to learn more?

Contact us to schedule a demo of Cortellis CMC Intelligence.

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