CognitiveSpark™ for Regulatory

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Regulatory intelligence solution to enhance strategies and accelerate submissions

The tool you need to generate regulatory insights that improve regulatory decision-making and accelerate time to market.

Why CognitiveSpark™ for Regulatory?

Unlock insights that transform regulatory strategies, planning, and submissions

Life sciences organizations face many challenges managing regulatory information and intelligence. Global regulatory requirements are often managed across multiple systems, company interpretations are stored within local markets, and associated experiences are often unavailable. The result? Suboptimal submissions decision-making, inefficient global filing planning, and reduced submissions quality.


CognitiveSpark for Regulatory simplifies this process by enabling:

  • Seamless access to regulatory information by housing requirements and integrations with internal and external sources.
  • Ability to provide guidance, collaboratively comment, and conduct impact assessments for legislations.
  • Advanced analytics with key insights that inform submissions planning and regulatory strategies.

Our CognitiveSpark for Regulatory intelligence solution provides users with an intuitive and user-friendly interface, supporting the industry in bringing medications to market faster.

Download the sales sheet

The benefits

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Improved decision-making

Seamless access to all regulatory insights—including up-to-date global submissions requirements—allow for optimized planning and submissions delivery.

Increased submissions efficiency

Remove the challenges and manual effort in finding accurate and up-to-date submission requirements, company experiences, and market activities.

Enhanced compliance

Submissions content and assembly is consistently based on accurate, up-to-date internal and external information.

Continuous innovation

Progressive enhancements, including new features and capabilities, provide users with the latest innovations.

Tailored user experience

Our user-friendly, intuitive interface is strategically designed with regulatory users in mind.

Reduced cost of ownership

A single, global system removes the need to maintain and operate multiple systems to collect, house, analyze, and generate insights.

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Solution capabilities

Granularity in requirements

Requirements contain detailed information, including Health Authority position, company interpretations, and associated submission experiences.

Regulation
management

Manage regulations end- to- end, from draft to final guidance into requirements, including the ability to collaborate on assessments.

Dashboards and
analytics

Pre-configured dashboards provide instant and deep insights for regulatory strategies and submissions.

Audit trail

A full audit trail of all regulatory requirement changes and updates provides of-the-moment visibility.

System
integrations

Easy integration with your regulatory information management (RIM) ecosystem allows for ease in data transferability to upstream and downstream systems.

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Putting customers at the center

The demand for better customer experiences and advanced products and services continues to accelerate. As motivations and needs continue to evolve, customers expect a differentiated and tailored experience. Customers will switch to providers who do this, making it critical for your business to anticipate and respond with products, services, and insights.

ConvergePROSPERITY™ was created for this moment.

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Ready to get started?

Ready to get started?

Connect with us to learn how CognitiveSpark for Regulatory can meet your business needs.

Amy Cheung

Mukesh Singhal

Regulatory Industry Leader
Principal, Deloitte Consulting LLP
msinghal@deloitte.com

Kent Mackenzie

Chris Brown

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