Accenture Life Sciences Rethink Reshape Restructure for better patient outcomes. Accenture Accelerated R&D Services: Regulatory Services Overview

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1 Accenture Life Sciences Rethink Reshape Restructure for better patient outcomes Accenture Accelerated R&D Services: Regulatory Services Overview

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3 Bringing to clients a comprehensive set of regulatory solutions that help increase quality, effectiveness, and efficiency. Regulatory organizations in Life Sciences are facing unprecedented business pressures. Increasingly stringent, globally driven health authority requirements have created varied and complex product obligations for initial filings, lifecycle management and ongoing compliance. These pressures have intensified the challenge of maintaining authorization for a full portfolio of commercially available products, while continuing to innovate and progress new investigational compounds. Regulatory organizations are confronted with the challenge of supporting expansion to new patients and geographies, market desire for differentiated therapies and a simultaneous mandate to find more effective and efficient ways to operate. Meeting these mandates strains current capacity and diverts precious resources from the desired focus: bringing differentiated new products to patients. Accenture offers a comprehensive set of regulatory service options and solutions, designed to help regulatory organizations relieve capacity constraints, secure authorization and sustain global compliance. Our regulatory clients have realized improvements in submission ready deliverables, reduced cost of submission and ongoing maintenance, and streamlined operations. 2

4 Accenture helps clients improve regulatory quality, speed and operating efficiency. Providing the industry s first comprehensive, global, full-lifecycle regulatory solution Accenture has incorporated Octagon Research Solutions capabilities into our offerings to provide a comprehensive and informed solution to help meet the needs of regulatory leaders. Accenture is a global organization with a dedicated Life Science practice that has a unique and insight-driven point of view on today s end-to-end regulatory requirements. We understand the nuances inherent in managing global regulatory affairs and operations. We have direct insight into the practices required to create first-time quality, submission-ready components, and to increase the efficiency and effectiveness of regulatory submissions. During our two decades serving regulatory organizations, we have fine-tuned and created industrialized regulatory solutions and services. We are able to tailor solutions to address our clients business needs. Our extensive experience combined with our strong performance-orientation and focus on continuous improvement allows us to build the controls and tools for robust yet flexible regulatory solutions. Match the solution to the challenge We offer a suite of services relevant to a pharmaceutical company s needs in regulatory affairs and regulatory operations (see Figure 1): 1. Strategic Regulatory Services: Our strategic regulatory services provide focused solutions to help our clients enhance their Regulatory Affairs organization s effectiveness and compliance. We provide specific functional services to complement our clients core activities. Our services include providing CMC baselining activities, regulatory intelligence and tracking, research services on drug regulatory pathways for submissions, CTD/eCTD related topics and enabling our sponsors to interact with Health Authorities. These can be coupled with transformational consulting or targeted operational-improvement efforts. We help seamlessly connect clinical and regulatory processes, unifying regulatory information with the regulatory organization s submission strategy. 3

5 2. Global Submissions Management: Accenture has the ability to operate as an extension of our sponsors regulatory organization. We provide a holistic submission capability which can be utilized to deliver submissions by type (across the full product lifecycle) and/or by geographic area. Using the Quantum technology platform, along with industry-proven SOPs and working practices, our global submission management services incorporate skills, scale and global access through a common platform. Our submission teams can be expanded or contracted to meet the ebb and flow of our clients pipeline requirements. Services include, but are not limited to, submission planning and management, resource planning and coordination, content publishing and tracking, submissions assembly and review, component compliance checking, and final submission dispatch. 3. Proprietary Enabling Technologies: Our enabling technologies help clients in the areas of content management, authoring, regulatory intelligence, publishing, tracking and performance measurement and management. Accenture s proprietary software environment includes Quantum, our market-leading regulatory information management solution. The Quantum platform is founded on an enterprise process management engine that provides comprehensive process management controls. It connects processes, automates tasks and provides the underpinning of cross-functional efficiency. Figure 1 Strategic Regulatory Services Regulatory Affairs Regulatory Intelligence CMC Regulatory Information Management Regulatory Operations Labeling Global Submission Management (Full product lifecycle) Proprietary Enabling Technologies Investigational applications Global marketing applications Amendments Agency correspondence XEVMPD Content Manager Authoring Regulatory intelligence Variations/supplements Safety updates (PADER/PSUR) Renewals Responses SPL Publishing Assembly Tracking Metrics & Performance Management 4

6 Only Accenture has the proven combination of technology, service and performance-orientation to help drive successful R&D outcomes. Accenture s unique capability and experience We work with Life Sciences clients in more than 50 countries, including industry leaders as well as 125+ public health organizations. We have a 20-year track record in offshore delivery, and our success has been widely recognized. Our continued investments demonstrate our commitment to regulatory technology and operations. We see regulatory as an area of significant market need and opportunity an area where improvements will lead directly to benefit patient outcomes. External recognition for Accenture For four years in a row, Accenture has been named the #1 outsourcing company by International Association of Outsourcing Professionals. For the second year in a row, IDC Health Insights selected Accenture as the #1 Preferred Life Sciences Technology vendor. Gartner again placed Accenture in the leaders quadrant for business process outsourcing (BPO). Deep regulatory experience 20+ years helping clients in regulatory Pioneered R&D outsourcing and currently support five of the top 10 pharmaceutical companies in BPO Direct operating experience in regulatory submissions, with 350+ experienced professionals Among the top users of the FDA electronic submissions gateway FDA s preferred provider of CDISC data conversion and training services original applications submitted to regulatory agencies, including 74 SDTM-based submissions to the FDA Operational excellence and continuous improvement Business process outsourcing for the entire regulatory submission lifecycle Understanding of how to enhance any process for improved productivity, with a focus on quality and innovation Industry-leading technology platform and advanced analytics Proprietary software or ability to work across other vendor s software - ViewPoint /QUANTUM: A purposebuilt platform designed to streamline regulatory information management from data collection to submission - Includes differentiated process management engine credited with cutting timelines by 30% Extensive services around software Advanced analytics that provide informed insights and help drive alignment across functions and within the regulatory organization. Global delivery and reach 50+ global delivery locations, with combination of onshore and offshore professionals 2,000+ professionals around the globe focused on R&D services Dedicated delivery teams who deeply learn clients processes and systems, and continuously look for improvement opportunities on client s behalf. Accenture has helped regulatory organizations achieve: 100% of submission schedules Reduced clinical/non-clinical error rate to 5% Increased efficiency and reduced cost of operations by 40% Improved reports quality by 30% Implemented improved regulatory timelines, leading to reduced FDA audit/ questioning Increased agility to respond to changing regulatory requirements. 5

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8 Creating the future model of R&D Accenture continues to invest in our dedicated Life Sciences practice to provide to clients forward-looking R&D services. Through Accenture Accelerated R&D services, we bring the next-generation, fully integrated business service that delivers enhanced processes across the clinical, regulatory and pharmacovigilance functions around the globe. This solution, supported by outsourced operational activities and enabled by customizable technology platforms, will allow pharmaceutical companies to bring drugs to market faster, at less cost and with reduced execution risks. Further, the solution is cutting-edge, supporting maximum efficiency in R&D as well as the management and measurement of R&D processes. Advanced data analytics will drive innovation across your company and release the full value of the data. Contact us to learn more To learn more about how Accenture is helping companies, please visit accenture.com/lifesciences or contact one of our executives: David Boath Tom Oblak About Accenture Life Sciences Accenture s Life Sciences practice is dedicated to helping companies rethink, reshape or restructure their businesses to deliver better health outcomes and drive shareholder returns. We provide consulting, outsourcing and technology around the globe in all strategic and functional areas with a strong focus on R&D, Sales & Marketing and the Supply Chain. We have a long history of working hand in hand with our clients to improve their performance across the entire Life Sciences value chain. Accenture s Life Sciences practice connects more than 10,000 skilled professionals in over 50 countries who are personally committed to helping our clients achieve their business objectives and deliver better health outcomes for people around the world. About Accenture Accenture is a global management consulting, technology services and outsourcing company, with approximately 259,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world s most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$27.9 billion for the fiscal year ended Aug. 31, Its home page is Stay Connected accenturemanagementconsulting company/accenture Accenture Life Sciences Blog Accenture experts share insights and opinions on opportunities and challenges in the pharmaceutical and medical technology industry. Copyright 2013 Accenture All rights reserved. Accenture, its logo, and High Performance Delivered are trademarks of Accenture. mc379