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Cortellis Regulatory Intelligence

Confidently navigate the global pharma regulatory landscape, maintain compliance, and make strategic decisions with AI-assisted regulatory intelligence.

Global regulatory intelligence you can trust

Regulatory requirements evolve daily across global markets. In pharmaceutical development, a single missed update can delay approvals by months or halt market access entirely. That's why regulatory professionals need a comprehensive regulatory intelligence solution that's continuously updated, expertly curated, and backed by decades of industry knowledge.

Comprehensive global coverage

The industry's most extensive regulatory intelligence database, covering drugs, biologics, and medical devices across 80+ markets. Includes FDA AdComm transcripts since 2000, local regulatory summaries and daily updates – ensuring you never miss critical changes.

Curated by regulatory professionals

Every piece of regulatory intelligence in our platform is reviewed by our team of regulatory experts located globally. Unlike general AI tools, our subject matter experts with regulatory affairs backgrounds ensure accuracy, context, and relevance for pharmaceutical decision-making.

Trusted partner by top 20 pharma

Trusted by 100% of the top 20 pharmaceutical companies and regulatory agencies worldwide. Our deep domain expertise and "Ask the Expert" service provide direct access to regulatory intelligence professionals when complex challenges arise.

AI-powered regulatory intelligence for enhanced productivity

Meet our new AI-powered Cortellis Regulatory Assistant. Accelerate decisions with trusted AI, purpose-built to meet the precision and compliance standards regulatory professionals demand.

Multilingual conversational search

Ask regulatory questions naturally in your preferred language and get accurate AI-powered referenced answers via conversational search. No more complex database queries or manual document hunting.

Intelligent summarization

Summarize lengthy regulatory documents instantly, tailored to your preferred level of detail for quick decision-making.

Document comparison

Compare document versions in seconds — highlighting key regulatory differences between versions of the same regulatory requirement or guideline to spot changes instantly.

4.9/5 - Rated by early adopters for ease of use

Discover how the Cortellis Regulatory AI Assistant can transform your workflow

Unmatched regulatory data coverage

328k+
regulatory documents
320k+
source documents
2k+
regulatory summaries
6k+
intelligence reports
43
global comparison tables
46k+
English machine translations (38 languages)

The Regulatory AI Assistant will save us significant time and resources compared to searching manually, and we are already seeing how this will speed up internal enquiries and intelligence work.

Janeen Skutnik-Wilkinson Director, Regulatory Intelligence & External Engagement, Moderna

With Cortellis Regulatory Intelligence, we've been able to leverage and compile key sources of information to execute our responsibility as the regulatory intelligence professionals. We can easily stay on top of and share relevant changes to the rest of the organization.

Global Head Regulatory Intelligence and Policy Top 50 global pharma company

Cortellis Regulatory Intelligence has provided our organization with the necessary insights to confidently comply with regulatory guidelines. It is used every day to keep us up to date and stay compliant.

Regulatory Professional Specialty pharma company

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Want to learn more?

Contact us to schedule a demo of Cortellis Pharma Regulatory Intelligence Solutions.

Resources

Your AI-powered Regulatory Assistant Your AI-powered Regulatory Assistant
Infographic
Your AI-powered Regulatory Assistant
Accelerate decisions with trusted AI — saving time, reducing risk, and ensuring compliance.
Regulatory intelligence in Pharma: Measuring the ROI, now enhanced with AI Regulatory intelligence in Pharma: Measuring the ROI, now enhanced with AI
Report
Regulatory intelligence in Pharma: Measuring the ROI, now enhanced with AI
Measuring and communicating the ROI
Route Map to Patient Access - A strategy that ensures patient access to your asset across markets Route Map to Patient Access - A strategy that ensures patient access to your asset across markets
Report
Route Map to Patient Access - A strategy that ensures patient access to your asset across markets
Designing and executing a strategy that ensures patient access to your asset across markets
Webinar
How to overcome common challenges and drive towards regulatory excellence
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FAQs

Cortellis Regulatory Intelligence is a comprehensive AI-enhanced platform that provides pharmaceutical, biotech, and medtech companies with expert-curated regulatory intelligence across 80+ global markets. The platform combines 30+ years of regulatory expertise with over 300,000 regulatory reports, daily updates, and an AI Assistant to help regulatory teams navigate compliance requirements, accelerate approvals, and make informed strategic decisions.

Regulatory intelligence software streamlines the complex process of monitoring and analyzing global regulatory changes. It helps pharmaceutical companies by: providing centralized access to regulatory requirements across multiple markets, offering real-time alerts on regulatory changes that could impact products, enabling comparative analysis of requirements between countries, reducing the time spent on manual research and documentation, and supporting strategic decision-making with expert-analyzed insights. This ultimately leads to faster approvals, reduced compliance risks, and more efficient regulatory operations.

The AI Assistant enhances your access to our comprehensive regulatory intelligence through conversational search, document summarization, version comparison, and multilingual support. Simply ask questions in natural language, and the Assistant provides accurate, referenced answers based on our expert-curated content. It can summarize lengthy documents, compare regulatory requirements between document versions, and interact in your preferred language – all while maintaining full transparency about sources and references.

We strongly believe that we have a critical responsibility to the regulatory community to mitigate AI-induced inaccuracies, and we take many steps toward achieving this goal:

  • The prompts used in our products are crafted by expert prompt engineers who ensure that the settings of the LLM are optimized to maximize faithfulness to the source content and minimize hallucinations. Our system is designed to provide references to the source text when delivering an answer. Additionally, our systems can handle negative rejections, ensuring that it does not fabricate one when an answer cannot be provided due to insufficient information. Instead, the system presents an explanation to the user for the lack of response.
  • The information presented to users always originates from our trustworthy, curated content. We use a combination of RAG models to ensure that the information users see is based on the vetted content your organization can access via Cortellis Regulatory Intelligence. Our tools offer full transparency regarding the content that was used to generate the response and ensure proper attribution to the specific sources used.
  • We continuously test our solutions and the results they produce, including thorough dedicated beta programs and close collaboration with customers and subject matter experts. Our data science expertise helps increase system accuracy, fairness, robustness and interpretability in a programmatic way.

The ranking and prioritization of sources by our AI-based discovery tools will vary according to the specific characteristics of the user’s query and the context of each query. The approach to ranking and prioritization is similar to the way it is traditionally done in the Cortellis Regulatory Intelligence platform. This understanding enables us to present the most relevant and valuable sources first, ensuring that the information provided matches the user’s needs as closely as possible.

Ensuring clarity and trust in our solutions is one of our top priorities. Our conversational search and AI-powered tools present a list of regulatory resources on which their responses are based, so that you can always explore relevant materials for further context.

Data privacy and trust are top priority when designing our AI tools. We comply with data privacy regulations and adhere to the evolving global AI legislation.

As part of the user query, only the content that users themselves input into the query is transmitted to the LLM. No additional data is shared during this process, ensuring the protection of sensitive information. Furthermore, we are not using any of the LLM API endpoints directly but accessing LLMs through a private setup. This ensures that data entered by users in the query stays protected and cannot be seen or accessed by any other party. For more information on our privacy and data protection program, visit: https://clarivate.com/privacy-center/.

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