1. The document discusses Quintiles' expertise in providing integrated regulatory filing and registration services to help biopharma companies navigate increasing challenges in drug development. 2. Quintiles leverages over 30 years of regulatory experience and integrated expertise across medical writing, biostatistics, and regulatory affairs to develop strategic filing plans and compile high-quality dossiers. 3. Their approach combines efficient processes with world-class functional expertise to analyze data holistically, minimize risks, and present evidence in a way that increases the likelihood of regulatory approval.

1. 1 Source: Quintiles internal data as of February 2013
Increasing Predictability of Success
Biopharma has looked to low-cost solutions for resourcing as development costs rise. However, with the number of new
chemical entities (NCEs) declining, increasingly complex protocols, and diverse regulatory expectations, managing these
challenges requires deep technical and strategic expertise.
With over 30 years of regulatory experience, only Quintiles has the combined expertise to fully understand the specific challenges
and needs associated with each filing. We leverage our broad operational and strategic knowledge (e.g. safety, regulatory,
biostatistics, etc.) during strategy development and dossier preparation as well as in post-filing support. Tapping into this
integrated expertise allows us to appropriately package and present all the information necessary to allow regulatory authorities
to make the right decision.
Unsurpassed Performance and Experience1
>> Approximately 1,000 eCTD submissions to the EU, the US and Canada—100% have passed technical validation
>> 50+ INDs and 15 million pages published (all document types e.g. eNDA/amendments)
>> ~1,200 global regulatory professionals average over 16 years of experience, 70% with advanced degrees
>> ~550 biostatisticians and statistical programmers averaging 7 years of experience and 65% with advanced degrees
>> ~60 medical writers and publishers average over 8 years of experience and 42% are MDs or PhDs
Strategic Expertise and Tactical Efficiency
The Quintiles 4-point approach to delivering end-to-end global filing and registration support brings together efficient processes
and integrated world-class expertise in biostatistics, medical writing, and regulatory affairs.
1 GLOBAL KNOWLEDGE
Local presence in 65 countries and a deep understanding of local, regional
and global regulations
2 FLEXIBLE SOURCING
Flexible sourcing, hybrid onshore/offshore models capture strategic and
tactical efficiencies
3 EFFICIENT PROCESSES
Integrated expertise increases efficiency through minimal handoffs,
decreasing potential risks to quality
4
LEADING, INTEGRATED
EXPERTISE
Integrated Medical Writing, Document Publishing, Biostatistics and Global
Regulatory functional expertise and processes combine into a seamless
registration solution to write the most compelling dossier possible
Integrated Submission
REGULATORY FILING AND REGISTRATION
AT-A-GLANCE

2. Copyright © 2013 Quintiles. 02.02.04-032013
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Direct: +1 973 850 7571
On the web: www.quintiles.com
Email: clinical@quintiles.com
The Advantages of an Integrated Approach
We bring together the right expertise and have developed efficient processes for analyzing and presenting the data holistically.
>> Engage early: Maximize your chance of success by taking into account different perspectives when developing your overall strategy
and help to identify gaps and troubleshoot any potential hurdles
>> Develop specific global and local filing strategy: When you tap into Quintiles expertise, we can help you determine how best to
enter new geographies
>> Outsource efficiently: We help you scale up operations swiftly with multiple sourcing models to best meet your needs (e.g. hybrid
onshore/offshore models)
>> Effective cross-functional communication and systematic handoffs: When processes are integrated you decrease quality risks by
taking a truly holistic approach to analyze, interpreting, and packaging evidence
>> Developing high quality dossiers: Together, our holistic approach to planning and execution results in evidence presented in the
optimal way to minimize the chance of queries back from regulatory agencies
How it Works
Our combined expertise informs every aspect of the regulatory filing and registration process from planning through post-filing
support to help produce high quality, accurate regulatory dossiers.
Plan
Engage Early
>> Gap and SWOT
Analyses
>> Agency meetings
>> Marketing
Authorization Strategy
and RMP
>> Data Integration Plan
and SAP
Combined Expertise
>> Biostatistics
>> Medical Writing
>> Regulatory Affairs
>> Document Publishing
Effective Analysis
>> CDISC SDTM/ ADaM
>> Database integration
>> Cross functional analysis
and interpretation
>> CTD / Marketing
Authorization Dossier
Writing
Efficient Filing &
Registration
>> Document Publishing
>> Data and document
compliance and filing
acceptance
Engagement Beyond
Submission
>> Dedicated rapid
response team to
manage regulatory
questions and requests
during assessment
360° Information
Interpretation
Analyze &
Interpret
File
Post-Filing
Support