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Regulatory Services

Driving the next evolution of life sciences regulatory.

INTELLIGENT LIFE SCIENCES [REPORT]

Redefining Regulatory through Intelligent Automation

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Regulatory redefined

The life sciences industry is evolving and advances in technology demand changes in the way Regulatory functions operate. Accenture is leading the next evolution by applying leading edge solutions across the drug and device lifecycle that unify innovative technologies with compliance-focused processes. These solutions include robotic process automation (RPA) and artificial intelligence (AI) as well as optimizing value from data by applying analytics. Accenture is helping life science companies capitalize on Intelligent Automation benefits that go beyond the tangible gains of cost, quality and productivity improvements. To learn more, take a deeper dive in our report: Intelligent Life Sciences: Redefining Regulatory through Intelligent Automation.

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Redefining regulatory through data automation

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Delivering future regulatory services. Now.

Industry shifts and advances in technology demand modifications to the way regulatory responsibilities are performed. Accenture is working with our clients to deliver compliance-focused regulatory outcomes to health authorities across the globe.

Regulatory Operations services

Supporting the entire submission process, from IND submissions to gaining global health authorities’ approval to lifecycle management.

Regulatory Affairs services

Helping to navigate Health Authority guidances to support global agency requirements including scientific, manufacturing, compliance and legal.

Technology and digital services

Achieving regulatory goals through our StartingPoint Template Suite, implementing RIM strategies or adopting our emerging digital technologies.

Consulting and strategy services

Global or regional, therapeutically diverse or indication focused, we help streamline processes and cost by reengineering regulatory businesses.

StartingPoint submission authoring suite

Helping companies achieve greater speed and efficiency in authoring, reviewing and publishing submission documents. Learn more.

Medical writing operations

Providing end-to-end regulatory medical writing services that meet expectations of regulators and the medical community.

Innovation in Regulatory: The art of the possible

Imagine a global, harmonized database where all information relating to medicinal product can be found. IDMP represents an opportunity to drive cross-functional solutions that bring together people, process, and data, breaking all the traditional silos industry has been struggling with to date.

Through the research conducted by the innovation team at The Dock, and collaboration with our regulatory practice, Accenture has brought together artificial intelligence and the need for regulatory compliance.

Explore how we are innovating with life sciences companies to adopt AI within regulatory functional groups such as Drug Labelling and CMC/Manufacturing to stay compliant. Learn more about innovation in regulatory.

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Accenture and TOPRA IDMP Readiness Webinar

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AI in Regulatory

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Enabling IDMP through technology

Our events

Knowledge of trends and insights are important to Accenture. Join our live thought leader-hosted events and watch on-demand sessions.

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What we think

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Women in Life Sciences

But why? The curious question of Azurii Collier

Azurii Collier shares her passion for neuroscience and what led her to where she is today.
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Case studies

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Life Sciences

Clinical biometrics & submission services in focus

Accenture’s Clinical Biometrics and Submission Services help a pharmaceutical company speed innovative therapy to patients.
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Life Sciences

Speeding an innovative cell therapy to market

A biopharmaceutical company collaborates with Accenture to navigate a complex FDA submission for an innovative cell therapy.
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Capabilities

Research and Development

We help reimagine R&D for pharma, bio and MedTech companies in a world that values patient outcomes.

Life Sciences

Combining new science with leading-edge technology to helping companies deliver better patient outcomes.

Meet our lead

Thomas Philipose

Managing Director – Technology, Life Sciences