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DESIGN ∙ TRANSFORM ∙ RUN
Life sciences Regulatory Affairs Intelligent OperationsSM
Design, transform and run intelligent r...
DESIGN • TRANSFORM • RUN 2© 2015 Copyright Genpact. All Rights Reserved.
We design, transform and run the intelligent ente...
DESIGN • TRANSFORM • RUN 3© 2015 Copyright Genpact. All Rights Reserved.
Domain + Technology + Analytics + Operations =
Re...
DESIGN • TRANSFORM • RUN 4© 2015 Copyright Genpact. All Rights Reserved.
Industry challenges
Solution portfolio
Impact
Cas...
DESIGN • TRANSFORM • RUN 5© 2015 Copyright Genpact. All Rights Reserved.
Rising volumes, complexity and costs push for tra...
DESIGN • TRANSFORM • RUN 6© 2015 Copyright Genpact. All Rights Reserved.
Genpact Pharmalink helps drive regulatory complia...
DESIGN • TRANSFORM • RUN 7© 2015 Copyright Genpact. All Rights Reserved.
Enabling efficiency, effectiveness and compliance...
DESIGN • TRANSFORM • RUN 8© 2015 Copyright Genpact. All Rights Reserved.
Genpact Pharmalink’s regulatory affairs solutions...
DESIGN • TRANSFORM • RUN 9© 2015 Copyright Genpact. All Rights Reserved.
About Genpact
Genpact (NYSE: G) stands for “gener...
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Intelligent regulatory affairs operations drive growth and compliance

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

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Intelligent regulatory affairs operations drive growth and compliance

  1. 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. 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. 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. 4. DESIGN • TRANSFORM • RUN 4© 2015 Copyright Genpact. All Rights Reserved. Industry challenges Solution portfolio Impact Case studies Life sciences regulatory affairs
  5. 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. 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. 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. 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. 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

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