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DNAnexus Regulatory Solutions 

Collaboration. Communication. Compliance.

Transform global regulatory collaboration and streamline regulatory workflows with cloud-based regulatory solutions built for life sciences.

DNAnexus regulatory solutions accelerate customers' R&D

Built for Confidence, Backed by Compliance
Delivers a secure environment built on a full-suite data platform—supporting data ingestion, management, analysis and trusted collaboration.

Streamlined to Scale
Accelerates insights with workflow automation and integrated AI/ML—streamlining analysis, reducing rework, and enabling reproducible science.

Powering Collaboration and Reliance
Enables secure collaboration across organizations while supporting regulatory reliance—aligning data sharing and evidence generation with regulatory expectations.

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Explore the capabilities of Trusted Regulatory Spaces

The problem

The current regulatory submission environment is complex, fragmented, and inefficient, characterized by:

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Slow Cloud Adoption

Outdated technology and poor interoperability pose limitations, delaying life-changing therapeutics

Administrative Burden

Administrative Burden

Sequential submission processes are prone to errors and create bottlenecks, introducing significant cost and time burdens that impact organizations and patients

barrier

Barriers to Collaboration

Obstacles that impede trust, transparency and secure information sharing hinder work-sharing and reliance, stifling innovation

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Evolving Global Standards and Policies

Constantly shifting regulations and updates to standards complicate compliance and add layers of operational complexity, increasing risk

omar.serang

Omar Serang

Chief Cloud Officer
DNAnexus

vada.perkins

Vada Perkins

Vice President
Global Head of Regulatory Intelligence & Policy
Boehringer Ingelheim

ON-DEMAND WEBINAR:
Cloud Transformation through Trusted Regulatory Spaces

Navigating evolving global policy to simplify and accelerate regulatory operations

Our solution

DNAnexus Trusted Regulatory Spaces (TRS) provide a comprehensive cloud-based regulatory collaboration framework designed specifically to resolve these critical challenges:

  • Trust
  • Alignment
  • Efficiency

Trust

Trust

Fully managed security and compliance in a cloud-native platform that keeps getting better.

 

 

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Alignment

Alignment

Thoughtful data organization and enhanced collaboration, with full control.

 

 

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Efficiency

Efficiency

Take the pain out of regulatory data processing with automated, out-of-the-box workflows from ingestion through output.

 

 

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Discover how Trusted Regulatory Spaces empower organizations to navigate regulatory challenges and enable secure collaboration.

THE PROBLEM

The regulatory submission landscape is fragmented, with multiple initiatives operating in isolation, leading to inefficiencies and inconsistencies

deceleration

Slow Cloud Adoption

Outdated technology and poor interoperability pose limitations, slowing therapeutic discovery

no-results

Administrative Burden

Manual submission processes are prone to errors and create bottlenecks, delaying R&D progress

inflation

Increasing Volume & Complexity

Unmanageable, disharmonious data create roadblocks to actionable insights, increasing R&D costs

roadblock

Barriers to Collaboration

Obstacles that impede reliance and secure information sharing stifle joint problem-solving, stifling innovation

regulatory-compliance

Evolving Regulations

Shifting regulations complicates compliance and add layers of operational complexity, increasing risk

Resources

News and Media

DNAnexus and LORENZ Partner to Enable Collaborative Regulatory Submission Validation and Scientific Review in the Cloud via Trusted Regulatory Spaces

Companies have joined with industry leaders and FDA on Project PRISM to advance solutions that can improve the submission, review and ease of communication for human drug and biologics applications. Read more

DNAnexus Expands Relationship with Veeva to Advance Global Regulatory Collaboration

Companies come together to connect sponsors, agencies, and standards development organizations on a regulatory collaboration cloud.  Read more

FDA Selects DNAnexus to Power precisionFDA Collaborative Omics Environment in the Cloud

The partnership enables FDA to enhance precisionFDA capabilities for sponsor-reviewer interaction, add support for multi-omics, and provide a library of analytical, statistical, and machine learning applications, accessible to reviewers and powerful enough for bioinformaticians. Read more

 

Another cloud in the sky: FDA and industry team up to test PRISM, a new regulatory cloud submissions platform

DNAnexus, in partnership with LORENZ Life Sciences Group, is advancing cloud-based regulatory solutions with the precisionFDA platform to streamline submissions and improve industry collaboration. Read more

 

Discover how DNAnexus solutions can transform your regulatory operations