Cortellis Regulatory Intelligence

Navigate global
guidelines and
efficiently drive
strategic decisions
Be compliant, Staying current with the ever-changing regulatory landscape
increase approval is challenging, often introducing uncertainty around
maintaining compliance. Cortellis Regulatory Intelligence™
rates and expand is a timely and comprehensive database that spans all
to new markets regulatory functions across the R&D lifecycle, providing a
single point of access to:

Daily updates to Detailed summaries Helpful context from Full coverage of FDA
maintain network of (in English) of local proprietary regulatory AdComm meetings
historic and current regulatory practices and intelligence reports since 2001 and FDA
source documents reference documents to support strategy workshops since 2003

Leverage high quality,

comprehensive data
supported by extensive
domain knowledge
and expertise
Robust data

215K+ 80
215K+ regulatory documents 80 modules for
for drugs, biologics, medical country- and region-
devices and in vitro specific regulations
diagnostics (IVDs)

3,000+ 5K+
3,000+ exclusive English 5K inspection
translations for crucial documents
documents

Expert team

Geographically diverse Deep knowledge on key Translations by regulatory Manual report curation
with global breadth and issues and trends impacting professionals who are also ensures attention to detail
local depth your submissions native English speakers and high quality

"Cortellis Regulatory Intelligence

supports strategic decision making
and submission preparation,
and avoids the need to review
multiple data sources and handle
translations internally."
Regulatory Professional, mid-size pharma

Unlock the hidden insights in data

Increase the chances of approval and rapidly expand to new markets using our
comprehensive, timely, accurate, central source of regulatory information including FDA483s,
approval documents, inspection reports and submission forms.

Reports and analytics Global comparisons Regulatory summaries

Prepare for inspections, understand Efficiently compare regulations Quickly understand regulatory
approval trends, discern submission across countries – all from a single requirements across all aspects
needs and more. point of database access. of therapy development.

Make better decisions and accelerate innovation

Contact a representative to learn how Cortellis Regulatory Intelligence
can accelerate innovation for your organization, or visit clarivate.com/cortellis

About Cortellis
Make data-driven decisions with speed and certainty across the drug and device development lifecycle with the Cortellis suite
of life science intelligence solutions – including customized consulting and services delivered to your specific requirements.
Only Cortellis delivers the insights needed to accelerate innovation with confidence.

R&D continuum

Discovery and preclinical development

Clinical development and regulatory compliance

Portfolio strategy and business development

Generics strategy and development

Data | Insights | Consulting | Services

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