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CAPABILITY


Accenture Accelerated R&D Services: Regulatory Services

Our regulatory services create process efficiencies that streamline regulatory submissions and help pharmaceutical companies speed drug development.

Overview

Throughout the global life sciences sector, companies of all sizes face unprecedented challenges. A rapidly shifting industry landscape, evolving standards, and increasingly stringent regulatory requirements have raised the bar for new drug filings, lifecycle management and ongoing compliance. These pressures have made it harder to maintain authorization for commercially viable product portfolios, while continuing to focus on the science of new products.

Accenture helps life sciences companies to transform R&D processes and adopt a regulatory model that is proactive, transparent and enables innovation Through our consulting-led approach and technology-enabled services, we help our clients to increase overall quality and consistency across regulatory operations, reduce cost of submission and ongoing maintenance, and improve the submission-ready deliverables that advance newly approved products to millions of patients around the world. We have helped life sciences companies to:

  • Accelerate time-to-market by up to 12 months

  • Reduce cost of operations by 40 percent and overall costs by 30-50 percent

  • Achieve 5 percent reduction in clinical/nonclinical error rate

  • Gain 30 percent improvement in reports quality

  • Facilitate expansion into new geographies and gain compliance with evolving regulations

  • Improve regulatory timelines, leading to reduced FDA audits or questioning

  • Enhance standards adoption and improve overall data quality and transparency

  • Drive the end-to-end linkages between clinical and regulatory that transform R&D processes

  • Increase agility to respond to changing regulatory requirements

Contact one of our R&D professionals for more information about our services:

US: North East, South East & Mid Atlantic
Jeff Emme
Tel: +1 610 407 5125

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US: West & Central
Kim Assal
Tel: +1 913 319 1259 

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Outside of the US
Andy Gerrard
Tel: +44 (0) 203 626 1979

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Why Accenture

For over 20 years, Accenture has helped life sciences companies to advance the regulatory submission process and achieve powerful business outcomes. Through services for regulatory affairs and operations, Accenture supports all aspects of global submission management. Our deep experience and body of work includes:

  • Successful engagements with companies in over 90 countries, including 21 of the top 25 pharmaceutical firms

  • 720 original applications to global health authorities

  • 25,000 maintenance submissions for over 200 companies

  • 10,000 regulatory deliverables annually to global health authorities

  • More than 20 years of experience helping clients with regulatory submissions

  • Pioneer in R&D outsourcing—currently supporting five of the top 10 pharmaceutical companies with BPO solutions

  • Direct operating experience in regulatory submissions, with more than 350 experienced professionals

  • Among the top users of the FDA electronic submissions gateway

  • FDA’s preferred provider of Clinical Data Interchange Standards Consortium (CDISC) data conversion and training services

Additionally, our global delivery and reach is unmatched:

  • More than 50 global delivery locations, with onshore and offshore professionals

  • More than 3,000 professionals around the globe focused on R&D services 

Regulatory Operations

Accenture assists clients with all areas of global submission management and has earned a reputation as a leader in electronic submissions. We combine our deep regulatory knowledge with advanced technology and standards-based processes to deliver measurable business outcomes.

Our consulting-led approach has been effective for globally oriented clients requiring proven resources to manage overflow activities for core and non-core submissions; as well as emerging, specialty driven companies who access our turnkey support for original and lifecycle submissions to global health authorities. We provide a core team of operations and regulatory affairs professionals who provide service delivery through North American, Asia/Pacific and European hubs.

  • Comprehensive support for electronic, paper, hybrid, and eCTD submissions

  • eCTD services for NDAs, BLAs, MAAs, INDs, NDS and DMF applications

  • Dossier publishing and assembly, including defining, structuring and finalizing key regulatory documents

  • Management of global health authority interactions

  • Technical writing services to compile comprehensive documentation to support regulatory activities

  • On-site eCTD training solutions

Global Regulatory Affairs

Accenture’s regulatory affairs professionals offer significant industry experience and deep domain expertise to support complex global, regional and national regulatory strategies. We provide regulatory organizations with the flexible capacity to meet current and future demands and focus on core growth activities.

  • Strategic regulatory affairs support throughout all phases of the drug development lifecycle, including product regulatory strategy development; authoring of regulatory summary documents; Established Products maintenance (Product Enhancements, CMC and Labeling Changes, Renewals, Annual Reports); and global health authority interaction.

  • Functional services and staff augmentation resources to support regulatory submission management; dossier publishing and assembly; regulatory intelligence; and regulatory technology platform management.

  • Transformational consulting services to implement best practices in regulatory strategy development and processes, publishing and submission management and facilitate targeted operational improvements.

Accenture offers one of the industry’s largest and most experienced regulatory affairs groups with skilled professionals across North America, Europe, and the Asia/Pacific region. This global footprint enables us to rapidly mobilize a worldwide network of qualified regulatory affairs resources within any geographic location. 


Regulatory Consulting

Accenture harnesses the broad experience of our global regulatory team to offer consulting services that help life sciences companies implement regulatory best practices and facilitate targeted operational improvements. Leverage our subject matter expertise, we offer proven experience in the standards, processes, and technologies that enable regulatory information management (RIM) development and drive electronic submission capabilities within sponsor companies.

  • Electronic submission capability assessments and recommendations

  • Global submission standards and process development

  • Submission content standards and process development

  • RIM technology implementation leadership and support

  • Change management leadership and support


    Regulatory Strategy

    Accenture’s regulatory affairs team delivers the depth and breadth of capabilities that help global life sciences companies manage the complexities of the regulatory environment.

    Our regulatory affairs professionals serve as trusted advisors to life sciences companies on all aspects of the regulatory affairs strategy. They help reduce cost and increase efficiency, while maintaining quality and compliance throughout the product lifecycle.

    • Accenture delivers a sophisticated understanding of regulatory guidelines and intelligence to improve the quality of clients’ regulatory strategies.

    • Cross-functional input on technical and non-technical components of regulatory strategies, informed by regulatory intelligence.

    • Consistent, process-driven focus that adapts to emerging global health authority requirements and meets evolving data and submission standards.

    Accenture facilitates the adoption of a regulatory model that is proactive and predictable, helping drive strategic innovation and maximizing the ability of sponsor companies to maintain existing product portfolios.

    Regulatory Intelligence Services

    Leveraging Accenture’s global presence and industry engagement, our professionals apply their sophisticated knowledge of regulatory guidelines to help clients stay abreast of the changing environment. Our regulatory affairs consultants provide comprehensive regulatory intelligence capabilities that support the development of sound, proactive submission strategies. We assist our clients by identifying potential regulatory hurdles and applying up-to-date intelligence to better facilitate compliance with regional and local requirements and support successful review.

    • Research and analysis of regulatory developments and their impact on specific stages of the drug/device development lifecycle.

    • Delivery of robust intelligence that is most relevant to clients’ business and product strategies via periodic news alerts, white papers, reports and summaries of key regulatory actions and meetings.

    • Ongoing surveillance of the regulatory landscape in local and/or cross regional markets on an ongoing basis.

    Based on clients’ goals and needs, Accenture subject matter experts and regulatory strategists provide highly-tailored information that focuses on the potential impact of current or anticipated regulatory challenges for clients’ developmental and approved therapies. 

    Integrated Sourcing

    With Accenture’s Integrated Sourcing model, life sciences companies can maximize their operational efficiencies through the tight integration of technology-enabled resources across the document, data and submission lifecycle. Integrated Sourcing offers seamless flexible capacity and predictable service delivery throughout the drug development cycle. Resources can be accessed at any time throughout the submission process and teams can be quickly expanded or contracted to meet the ebb and flow of cyclical business needs. Integrated Sourcing offers:

    • On-demand resources for submission planning, content tracking, publishing, reviewing, data compliance checking, dispatching submissions, and other activities.

    • Transitional capabilities to clients moving from outsourcing toward technology acquisition.

    • Service flexibility that enables the use of clients’ existing software platform as needed. 

    Submission Stewardship Program

    The Accenture Submission Stewardship Program (SSP) offers full lifecycle management of the submission process with flexible options for report-level publishing, submission publishing, compilation, and lifecycle maintenance.

    The Submission Stewardship Program provides complete eCTD capabilities delivered in a comprehensive outsourcing model. It is ideally-suited to companies who are considering enhancing their in-house eCTD capabilities in the future. As part of the SSP, Accenture partners with clients to steward regulatory information through the submission lifecycle. These companies have access to Accenture’s full electronic submission capabilities on a long-term basis, easing the burden and mitigating the risk associated with internal eCTD adoption and implementation.

    • Provides full outsourcing support for regulatory submission requirements

    • Offers strategic individual services to complement internal capabilities

    The SSP extends the capabilities of life sciences companies, increases potential capacity, and provides the first-hand experience and knowledge that will support the transition to an internal eCTD infrastructure. Accenture has submitted over 25,000 maintenance submissions through the SSP for over 200 clients.

    Submission Survival Kit Training

    The Accenture Submission Survival Kit Training offers comprehensive training that covers all aspects of the FDA submission process:

    • Provides a checklist and process for completing an NDA/BLA submission including strategic planning, requirements gathering and application filing.

    • Training is ideally suited for:

      • Companies who are new to the submission process.

      • Organizations who want to enhance their current knowledge and expertise on submission best practices, tools and processes.

    • Upon completion of training, clients will have the required knowledge to implement clinical and regulatory submission strategies for planning and filing an FDA submission.

    Program Topics:

    • FDA Final Guidance Documents

    • Overview of Submission Compliant Deliverables

    • Managing Issues and Challenges in the Submission Process

    • Helpful Tips for a Successful Submission