REGULATORY INTELLIGENCE
THOMSON REUTERS
REGIONAL OFFICES
USE CORTELLIS REGULATORY INTELLIGENCE TO:
WHAT’S PROVIDED:
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An unparalleled depth and breadth of
regulatory intelligence
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Support from a global in-house team of
regulatory experts
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Alerts on regulatory changes as they happen
•
Tracking of versions and history of changes
•
Documents obtained through FOI requests
•
Exclusive English translations for Brazil, China,
Japan, Russia, South Korea and Taiwan
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Combined searches across multiple countries
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Access continuously updated regulatory
intelligence
Benefit from exclusive regulatory information
and analysis
Track regulatory changes
Understand submission routes and local
regulatory practices
Compare regulatory requirements across countries
Learn from regulatory precedence
Compare existing and emerging
competitive products
Prepare for committee meetings and inspections
THE CHALLENGE
THE SOLUTION
Keeping up to speed with the ever-changing global
regulatory environment is vital to professionals
involved in the clinical development, launch, and
post-marketing surveillance of drugs.
Thomson Reuters Cortellis™ Regulatory Intelligence
is your single, comprehensive source for global
regulatory information to help you make faster, more
informed decisions.
With many different sources of information, finding
and analyzing what you need for submissions and
beyond is a time-consuming task. To make the right
decisions for your organization, fast access to accurate
information can make all the difference.
Access and benefit from trusted content to ensure
efficiency and regulatory compliance:
• Understand the local regulatory environment in all
countries where you do business
• Save time tracking regulatory changes
• Easily share information across your organization
• Anticipate regulatory obstacles with accessible
analytics
CORTELLIS REGULATORY INTELLIGENCE
Regulatory Intelligence Solution for Professionals
Covering 80 Countries and 140,000 Documents
Compare regulatory country
requirements side by side
Apply digested
regulatory reports
Understand regional practices
and submission routes
Access new and historical
regulatory documents
Add on:
Analytics
GLOBAL
REGULATORY
COMPARISONS
REGULATORY
INTELLIGENCE REPORTS
REGULATORY SUMMARIES
Use dynamic analytics to gain
deeper insights, understand
patterns and prepare strategically.
Add on:
Regulatory Online Learning
19 courses covering key regulatory
areas with in-depth coverage to
advance your expertise.
REFERENCE DOCUMENTS
Professional Services
Regulatory Specialists and Local Regulatory Consultants
North America
Philadelphia +1 800 336 4474
+1 215 386 0100
Latin America
Brazil
+55 11 8370 9845
Other countries+1 215 823 5674
Europe, Middle East and Africa
London
+44 20 7433 4000
Asia Pacific
Singapore
+65 6775 5088
Tokyo+81-3-4589-3179
For a complete office list visit:
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Copyright ©2015 Thomson Reuters
THOMSON REUTERS CORTELLIS REGULATORY INTELLIGENCE
AVAILABLE REGION MODULES
• ASEAN
• European Union
• Gulf Cooperation Council (GCC)
• International
• Mercosur
• SICA
AVAILABLE COUNTRY MODULES
• Algeria
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Bulgaria
• Canada
• Chile
• China
• Colombia
• Costa Rica
• Croatia
• Cyprus
• Czech Republic
• Denmark
• Egypt
• Estonia
• Finland
• France
• Germany
• Greece
• Guatemala
• Hong Kong
• Hungary
• Iceland
• India
• Indonesia
• Iraq
• Ireland
• Israel
• Italy
• Japan
• Jordan
• Kenya*
• Latvia
• Lebanon
• Lithuania
• Luxembourg
• Malaysia
• Malta
• Mexico
• Morocco
• Netherlands
• New Zealand
• Nigeria*
• Norway
• Panama
• Peru
• Philippines
• Poland
• Portugal
• Romania
• Russian Federation
• Saudi Arabia
• Serbia
• Singapore
• Slovakia
• Slovenia
• South Africa
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• Thailand
• Tunisia
• Turkey
• Ukraine
• United Arab Emirates
• United Kingdom
• USA
• Venezuela
• Vietnam
* ANTICIPATED 2015
Copyright ©2015 Thomson Reuters
Cortellis Regulatory Intelligence is an intuitive and
comprehensive intelligence tool. See the full picture of the
regulatory landscape, and reach critical decisions more
efficiently. Reduce the time you spend searching and
analyzing information by starting from one central point:
• Global Regulatory Comparisons – Compare
regulatory requirements in countries and markets of
your interest, covering the critical areas of regulatory
including pharmaceutical laws and regulations,
electronic submissions, expected review times, clinical
trial applications, fees, stability data and conditions
for finished products, packaging/labeling, preand-post marketing pharmacovigilance, certificate
of pharmaceutical products, Biosimilar products,
pharmacopeias and more.
• Regulatory Intelligence Reports – Exclusive
intelligence reports to support you with the analysis
of regulatory information. Plan your multi-country
filing in Europe, stay ahead of legislations and
guidelines, use Product Information tables to
compare existing and emerging products, identify
new indications for your product and prepare for
committee meetings and inspections.
• Regulatory Summaries – Continuously updated by
our experts, these summaries support your country
filings, guide you through individual countries
registration processes, and help you decide the
most efficient submission routes for your products.
• Reference Documents – Updated daily, this
repository of documents give you a complete
history of the regulatory landscape, giving
you additional insights and more context for
your research. This also includes documents
obtained through FOI requests, exclusive English
translations, and historical regulatory documents
that have been removed from agencies’ websites.
We also include Drug Approval Information from
various countries to help you compare and refine
your tactical plans.
ANALYTICS – QUESTION, EXAMINE, INTERPRET
AND COMPARE
Transform information into insight with Spotfirepowered regulatory analytics in Cortellis. Easily
exported to PowerPoint®, you can share and update
your findings quickly. Available as an add-on module
to your subscription, these dynamic visualizations help
you interpret data in a new way, providing actionable
answers faster.
FDA ADVISORY COMMITTEE MEETINGS
Strategically prepare for Advisory Committee
Meetings. These easily exported analytics help you:
• Gain intelligence on how a committee might
approach your product before it is under review
• Gain insight into similar products
• Better predict outcomes through a deeper
understanding of previous trends
FDA WARNINGS AND UNTITLED LETTERS
Analyze and learn from past events quickly and easily.
Use these analytics to:
• Progress towards a better compliance – View the
most commonly observed mistakes and identify
corrective measures needed to strengthen compliance
• Observe tendencies over time periods –
Understand what hits companies most currently
REGULATORY PROFESSIONAL SERVICES
Thomson Reuters has a dedicated regulatory services
team that includes regulatory professionals, industry
consultants and IT experts to support collaborations
beyond our core content capabilities. Our services
include:
• Customized regulatory newsletters
• Customized tables
• Regulatory landscaping reports
• Company internal documentation review and
management
CUSTOMER QUOTES
Very reliable information and customized support. Excellent, easy to find
and up to date regulatory knowledge. Makes my life easy and gives the
company an advantage over competitors.
Cortellis Regulatory Intelligence has more thorough coverage and accuracy
on valid as well as outdated document archival. Updates are regular and
extensive.
I use Cortellis on a daily basis and find it be a very valuable tool for my
regulatory role.
FOR MORE INFORMATION
Visit http://cortellis.thomsonreuters.com or contact Thomson Reuters.