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.
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.
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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Harness the power of Generative AI to transform your Health Authority Query’s (HAQs)
Deloitte’s solution augments the native Vault RIM HAQ capabilities by effectively deploying GenAI to automate data extraction, enable intelligent search, and auto-draft recommended responses. The solution enhances users’ ability to access and search past queries, generate insights that minimize future queries, and recommend responses – allowing for improved planning, increased efficiency, and faster global approvals.
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.
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Ready to get started?
Connect with us to learn how CognitiveSpark for Regulatory can meet your business needs.