Clarivate Cortellis Regulatory Intelligence is a comprehensive, AI-enhanced platform designed to help pharmaceutical, biotech, and medtech companies confidently navigate the complex and continuously evolving global regulatory landscape. The solution streamlines regulatory compliance, accelerates submission approvals, and supports strategic decision-making throughout the product lifecycle.
Key Benefits and Value Proposition:
- Unmatched Global Coverage: Provides the industry's most extensive regulatory intelligence database, covering drugs, biologics, and medical devices across 80+ global markets and regions.
- Expert-Curated Data: Every piece of intelligence is reviewed by Clarivate's team of regulatory experts, ensuring accuracy, context, and relevance, unlike general AI tools.
- Accelerated Productivity: The platform is trusted by 100% of the top 20 pharmaceutical companies and 88% of the top 25 pharmaceutical companies to reduce the workload of tracking regulatory changes.
Main Features and Capabilities:
- AI-powered Regulatory Assistant: A new capability featuring Conversational AI with referenced answers, intelligent summarization of lengthy documents, and document comparison to instantly spot key regulatory differences.
- Global Regulatory Summaries and Comparisons: Offers over 2,000 summaries and 43+ side-by-side comparisons, all in English, to easily compare granular requirements across multiple markets.
- Real-time Alerts and Mobile Access: Users can set up and monitor custom alerts via email or the Cortellis Regulatory Alerts mobile app to stay informed on the go with daily updates.
- Regulatory API: Provides programmatic access to global Drugs & Biologics regulatory information, including curated documents, summaries, and reports, enabling integration with internal systems.
- Precedent Insights: Includes FDA AdComm transcripts since 2000 and expert analysis from over 285k documents and 7k reports, including past approvals, to reduce risk and inform strategy.
- Ask the Expert Service: Provides direct access to regulatory intelligence professionals for complex challenges.
Target Users and Use Cases: Cortellis Regulatory Intelligence is built for regulatory professionals, regulatory affairs teams, and compliance officers within biopharma, medtech, and research organizations. Primary use cases include tracking evolving regulations, maintaining compliance, planning worldwide submissions, setting up regulatory submission strategies, and making strategic decisions on market access.