Life Sciences and Healthcare

Cortellis Regulatory Intelligence

Navigate global regulatory complexity with confidence

  • Stay compliant across 80+ markets with expert-curated intelligence from 300k+ source documents.
  • Reduce research time using AI-powered Regulatory Assistant for instant answers to complex regulatory questions.
  • Make confident strategic decisions backed by 2,000+ expert summaries, 40+ market comparisons and historical precedent.
  • Mitigate compliance risk with daily alerts, document version comparisons and 6k+ FDA inspection insights.
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Don’t fall behind in the global regulatory race

Cortellis Regulatory Intelligence delivers expert-curated regulatory intelligence trusted by top 20 pharma. From real-time alerts to AI-powered research and FDA AdComm data, we help regulatory teams reduce risk and accelerate approvals.

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Global coverage in real time

Stay ahead of fast-changing requirements with real-time regulatory intelligence across 80+ countries, covering drugs, biologics and medical devices.

Clear summaries and side-by-side comparisons

Compare detailed regulatory requirements instantly with 2,000+ expert-curated summaries and 40+ side-by-side comparisons—saving hours of manual work.

Real-time alerts and mobile access anywhere

Stay informed with daily alerts, mobile access and AI-powered search—helping you track global changes and respond quickly from any device.

Faster, smarter compliance management

Cut research time with AI-enhanced tool, expert-reviewed insights and structured updates that reduce risk and improve global approval timelines.

Struggling with compliance challenges?

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Inside Cortellis Regulatory Intelligence

See how leading pharma companies like Bayer and Moderna are transforming regulatory workflows with Cortellis Regulatory Intelligence AI Assistant.

With real-time updates, expert-curated insights, and AI-enabled guidance, regulatory teams can make faster, more confident decisions across the product lifecycle, access precise cited answers, instant summaries, and multilingual support—all in one seamless platform.

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The AI Regulatory Assistant has made it significantly faster for us to find the right documents. It understands specific requirements and provides foundational guidance, allowing our SMEs to focus on in-depth analysis rather than document searches.

Wendy Lara Senior Manager, FDA Business Excellence , Bayer

Clarivate has been very approachable and responsive to taking our business needs into consideration when working with the tracking application. We are now able to efficiently triage and manage our regulatory alerts, send out newsletters with ease and so much more!

Kinga Pallay Regulatory Intelligence Expert

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

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

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FAQs

Unlike tools that rely solely on automation or surface-level data, Cortellis Regulatory Intelligence combines 30+ years of regulatory expertise, a global team of regulatory-affairs professionals, and AI-enhanced capabilities to give users clarity, accuracy, and confidence in every decision. It offers unmatched global coverage across 80+ markets, spanning drugs, biologics, and medical devices. Users gain access to 300,000+ regulatory documents, daily updates, FDA AdComm transcripts dating back to 2000, 2,000+ regulatory summaries, 40+ side-by-side comparisons, and rich precedent insights that ensure no critical change is missed.

Every piece of intelligence is expert-reviewed, ensuring relevance and context that generic AI or unverified databases cannot match. The AI Regulatory Assistant speeds up research with instant answers grounded in curated data—not guesswork—helping teams reduce compliance risk and accelerate global submissions.

Cortellis Regulatory Intelligence provides comprehensive FDA compliance support including real-time updates on FDA guidance documents, policy changes and enforcement actions. Access 6,000+ FDA inspection documents to understand common inspection findings and proactively address compliance gaps. Review FDA AdComm meeting transcripts and voting patterns dating back to 2000 to understand approval precedent for similar products.

Yes. Cortellis Regulatory Intelligence data is curated by a global team of regulatory experts with extensive industry experience. All regulatory summaries and intelligence reports undergo expert review for accuracy. Our expert curation process ensures information is not only accurate but contextualized with local market practices and unwritten expectations that automated systems miss.

Cortellis Regulatory Intelligence sources data directly from official health authority websites and publications across 80+ markets including FDA, EMA, PMDA, NMPA. Our team monitors these sources daily, extracting and curating new guidelines, regulation updates, approval decisions, and enforcement actions. We provide 3,500+ expert human translations and 41,000+ machine translations of regulatory documents from non-English speaking countries, ensuring you can understand requirements regardless of source language.

Yes, you can leverage bulk data from this regulatory database as a data feed or API to populate internal data, business intelligence tools and analytics solutions. This enables integration with your existing regulatory systems and workflows while maintaining access to expert-curated content.

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