Cortellis CMC Intelligence
Navigate CMC regulations, local practice and submission requirements with trusted CMC intelligence, now enhanced with AI-powered discovery
Global CMC regulatory intelligence you can trust
CMC regulations evolve continuously across global markets, and missing critical requirements can delay approvals and increase submission risk. Cortellis CMC Intelligence brings together official CMC requirements, expert-validated local practice, and regulatory pathways into a single trusted platform.
Accelerate regulatory submissions
Expert-validated local practice
Compare requirements across markets
How Cortellis CMC Intelligence support CMC regulatory strategy
Comprehensive pre- and post-approval coverage
Access official CMC regulatory requirements for small molecules and biologics across the product lifecycle, from development through post-approval change management.
eCTD Module 3 organization
Navigate requirements in a standardized structure familiar to regulatory professionals, making information easier to find and compare.
Pathways, timelines and alerts
Monitor evolving regulations, visualize regulatory pathways and stay informed through continuously updated intelligence and configurable alerts.
AI-powered CMC intelligence for faster, more confident decisions
Meet the new Cortellis CMC AI Assistant. Access trusted CMC regulatory intelligence through a conversational experience.
Natural-language access
Ask CMC questions in plain language and receive structured responses grounded in trusted regulatory intelligence and expert-curated content.
Multi-market querying
Research requirements across multiple markets simultaneously and receive structured summaries and tables that support comparison and planning.
Transparent, referenced answers
Every answer links directly to the underlying source content, providing transparency, traceability, and confidence in the information provided.
Unmatched CMC regulatory coverage
137+
64+
7,000+
61+
Daily
Resources
Is the EU Biotech Act Europe’s innovation turning point?
Mastering Regulatory Complexity
Frequently asked questions
CMC regulatory intelligence is the process of collecting, analyzing, and monitoring regulatory requirements, guidance, and local practice related to Chemistry, Manufacturing and Controls (CMC). It helps pharmaceutical companies support CMC regulatory compliance, reduce submission risk, and strengthen global regulatory strategy.
Cortellis CMC Intelligence is a centralized CMC regulatory intelligence platform that combines up-to-date official requirements, local practice insights, regulatory pathways, and expert analysis across global markets to help CMC professionals make informed decisions with confidence.
Access to accurate, current regulatory requirements and local practice intelligence helps teams identify requirements earlier, avoid incomplete submissions, and reduce the risk of regulatory delays, rejections, and costly rework.
Cortellis CMC Intelligence includes CMC requirements and regulatory intelligence across more than 137 countries, territories, and organizations for small molecules and more than 64 countries and regions for biologics.
The Cortellis CMC AI Assistant provides conversational access to Clarivate’s curated CMC regulatory intelligence. Users can ask questions in natural language, explore requirements across markets, receive structured outputs, and review referenced source content used to generate answers.
Responses are grounded in Clarivate’s curated regulatory content and include source references that allow users to review the underlying information. The Assistant is designed to support regulatory research while maintaining transparency regarding the content used to generate responses.
Yes. Organizations can access CMC regulatory intelligence through multiple experiences, including platform search, configurable alerts, APIs, MCP-enabled workflows, and the Cortellis CMC AI Assistant, enabling teams to embed trusted intelligence directly into existing regulatory workflows.
