Re-imagine life sciences regulatory affairs through advanced operating models that ‘industrialize’ operations and support growth and compliance, while reducing costs.

1. DESIGN ∙ TRANSFORM ∙ RUN
Life sciences Regulatory Affairs Intelligent OperationsSM
Design, transform and run intelligent regulatory affairs operations to manage
costs, enhance compliance and support growth
EXECUTE
ACTIONS
http://www.genpact.com/home/industries/life-sciences/regulatory-affairs
Gianni Giacomelli
Senior Vice President
Head of Genpact Research Institute
Chief Marketing Officer

2. DESIGN • TRANSFORM • RUN 2© 2015 Copyright Genpact. All Rights Reserved.
We design, transform and run the intelligent enterprise
operations that strengthen our clients’ competitiveness
About Genpact ► Overview
*US$22B is a cumulative figure since 2006
*Cumulative figure since 2006
Whatwedo
Help leaders of some of the largest enterprises
…design, transform and run
…business-critical operations including the very complex
and industry-specific
Howwedoit
Smart Enterprise Processes (SEPSM) crystallizes
operational and domain expertise, rigor inherited from GE
Achieve Intelligent OperationsSM through Systems of
EngagementTM, Core IT and Data-to-Action AnalyticsSM
The strength of a large company, but flexible solutions; top
management directly involved with clients
Unbiased and agile solutions limit upfront costs, reach
results faster and enhance adaptability
Our impact
We make clients
more competitive:
• More efficient,
effective
• Able to better
manage costs,
risks, regulations,
and support growth
The results:
US$22B*+ of impact
for 800 global clients

3. DESIGN • TRANSFORM • RUN 3© 2015 Copyright Genpact. All Rights Reserved.
Domain + Technology + Analytics + Operations =
Reimagine processes, build Intelligent Operations
Genpact Intelligent Operations SM
Genpact Intelligent OperationsSM
EXECUTE
ACTIONS
EXECUTE
ACTIONS
Smart Processes
Design, transformation and
operations support generate real
impact by aligning tightly to
measurable business outcomes
thanks to proprietary SEPSM
framework
Smart Decision Services
Genpact Data-to-Action AnalyticsSM
leverage Intelligent Process Insight
EngineSM and advanced
organizational delivery models
Smart Technology
Genpact Digital harnesses effective,
agile technology including Genpact
Systems of EngagementTM and
effective Core IT services

4. DESIGN • TRANSFORM • RUN 4© 2015 Copyright Genpact. All Rights Reserved.
Industry challenges
Solution portfolio
Impact
Case studies
Life sciences regulatory affairs

5. DESIGN • TRANSFORM • RUN 5© 2015 Copyright Genpact. All Rights Reserved.
Rising volumes, complexity and costs push for transforming
global regulatory affairs operating model
Life sciences regulatory affairs ► Industry challenges
Increasing volumes
and complexity
hamper speed to
market
Rising costs of
maintaining products
in market
Current operating
model not
sustainable
Faster time to market key to maximizing revenues from
products, but growing number of new product
introductions, number of global markets served and,
alliances and acquisitions increase complexity and workload
Regulatory affairs must manage risk and global compliance
cost effectively to counter lower revenue and high cost of
maintaining mature products with loss of exclusivity,
competition from generics and reimbursement pressures.
Existing operating models relying on fragmented use of
contractors and ad-hoc projects are not sustainable with high
costs, inconsistent quality and lack of scale

6. DESIGN • TRANSFORM • RUN 6© 2015 Copyright Genpact. All Rights Reserved.
Genpact Pharmalink helps drive regulatory compliance
efficiency and effectiveness across the product life cycle
Life sciences regulatory affairs ► Solution portfolio
Regulatory
strategy
• Pre-IND/IND
• Filing strategy
• Product lifecycle management
• Authoring CTD modules
• Review of clinical study
protocols and reports
• Advertising and promotion
• Labeling
CMC pre approval
and post market
support
• Emerging market services
• Regulatory compliance
evaluation and remediation
• Risk assessment analysis
• Annual reports, renewals
Regulatory
operations and
maintenance
• Submission management
• Publishing operations
• Post-market surveillance
• NDAs/variations
• Annual and safety reporting
• Safety and PV
• Risk management services
Discovery
Preclinical
development
Clinical
development
Approval
Life cycle
management

7. DESIGN • TRANSFORM • RUN 7© 2015 Copyright Genpact. All Rights Reserved.
Enabling efficiency, effectiveness and compliance with
intelligent regulatory affairs operations
Life sciences regulatory affairs ► Impact
Up to 30% cost reduction through optimized resource
allocation with advanced operating models
Reduced costs of
regulatory affairs
operations
Robust risk
management and
compliance
Greater scalability
and speed to
market
Ensure regulatory compliance and optimize risk
management with robust process controls and integrated
regulatory processes across the product life cycle
• Higher throughput and faster turnaround time for key
regulatory compliance deliverables
• Access to global resources with in-depth knowledge of
local regulations and procedures
Effective
decision making
Advanced technologies and Data-to-Action AnalyticsSM
enable robust regulatory information management and
regulatory intelligence for insight-led compliance and
management decisions

8. DESIGN • TRANSFORM • RUN 8© 2015 Copyright Genpact. All Rights Reserved.
Genpact Pharmalink’s regulatory affairs solutions realize
measurable impact
Life sciences regulatory affairs ► Case studies
Challenge Solution Impact
• A fragmented
regulatory affairs
operating landscape
with 9 vendors and
over 140 contractors
• Without a provision for
end-to-end, modular
services, the client
resorted to staff
augmentation leading
to lack of scale,
inconsistent quality
and high costs
• Global Chemistry
Manufacturing Controls
(GCMC) support
• Decoupled processes
and industrialized
lower risk activities e.g.
annual reports,
regulatory intelligence
• Defined new SOPs and
data standards.
• Three global hubs,
supporting across
therapies, business
divisions in over 100
countries
• 30% cost savings
• Released resources
for value added
activities and strategic
initiatives
• Robust process
management with well
defined procedures,
metrics and
transparency on
performance
• Agility and scalability
to cater to new
geographies and
variation in volumes
Global
pharma
leader

9. DESIGN • TRANSFORM • RUN 9© 2015 Copyright Genpact. All Rights Reserved.
About Genpact
Genpact (NYSE: G) stands for “generating business impact.” We design, transform, and run intelligent business operations including those that are complex
and specific to a set of chosen industries. The result is advanced operating models that support growth and manage cost, risk, and compliance across a range
of functions such as finance and procurement, financial services account servicing, claims management, regulatory affairs, and industrial asset optimization.
Our Smart Enterprise Processes (SEPSM) proprietary framework helps companies reimagine how they operate by integrating effective Systems of
EngagementTM, core IT, and Data-to-Action AnalyticsSM. Our hundreds of long-term clients include more than one-fourth of the Fortune Global 500. We have
grown to over 68,000 people in 25 countries with key management and a corporate office in New York City. Behind our passion for process and operational
excellence is the Lean and Six Sigma heritage of a former General Electric division that has served GE businesses for more than 16 years.
For more information, visit www.genpact.com.
Follow Genpact on Twitter, Facebook, LinkedIn, and YouTube.
© 2015 Copyright Genpact. All Rights Reserved.
Genpact Research Institute
The Genpact Research Institute is a
specialized think tank harnessing the
collective intelligence of Genpact – as
the leading business process service
provider worldwide - its ecosystem of
clients and partners, and thousands of
process operations experts. Its
mission is to advance the “art of the
possible” in our clients’ journey of
business transformation and adoption
of advanced operating models.
www.genpact.com/research-institute