DNAnexus Strengthens Veeva Partnership for Global Regulatory Collaboration

DNAnexus Expands Relationship with Veeva to Advance Global Regulatory Collaboration

DNAnexus, a global leader in regulatory cloud services, has announced the expansion of its collaboration with Veeva Systems, a prominent provider of cloud-based software for the life sciences industry. This strategic initiative aims to enhance global regulatory collaboration through cloud-based solutions, driving efficiencies in regulatory research, submission, and review processes. The partnership will focus on integrating Veeva Regulatory Information Management (RIM) with DNAnexus Trusted Regulatory Spaces (TRS), creating a seamless and secure platform for international regulatory agencies, sponsors, and standards development organizations to collaborate effectively.

Background: DNAnexus and Veeva’s Strategic Partnership

DNAnexus has long been recognized as a pioneering force in cloud computing for the life sciences sector. With its regulatory cloud platform, the company provides cutting-edge solutions that facilitate secure data exchange, compliance management, and regulatory submissions. Veeva, on the other hand, is a leader in cloud-based solutions tailored to the unique needs of life sciences organizations. Its RIM software enables companies to efficiently manage regulatory information, streamline submissions, and maintain compliance across global markets.

The expanded partnership between DNAnexus and Veeva represents a significant step toward creating a unified regulatory collaboration cloud. By integrating DNAnexus TRS with Veeva RIM, the two companies aim to bridge the gap between sponsors and global regulatory agencies, improving transparency, security, and efficiency in the regulatory approval process.

The Role of Trusted Regulatory Spaces (TRS)

Trusted Regulatory Spaces (TRS) is a secure cloud-based framework developed by DNAnexus to facilitate regulatory collaboration. This platform enables global sponsors and regulatory agencies to establish trusted digital environments where they can share data, conduct analyses, and validate regulatory submissions in a secure and compliant manner.

Key features of TRS include:

  • Secure Data Exchange: TRS provides a highly secure and compliant environment for regulatory data sharing, ensuring that sensitive information remains protected at all times.
  • Multi-Agency Collaboration: The platform allows multiple regulatory agencies to work together in real time, reducing redundancies and improving the efficiency of drug approval processes.
  • Interoperability with Industry Standards: TRS is designed to align with global regulatory standards, making it easier for sponsors to navigate the complex landscape of international compliance requirements.

Integration with Veeva RIM

The integration of DNAnexus TRS with Veeva RIM is a game-changer for regulatory collaboration. Veeva RIM is already widely used by life sciences organizations to manage regulatory submissions, track approvals, and ensure compliance with evolving regulations. By connecting TRS with Veeva RIM, DNAnexus and Veeva aim to create a seamless workflow that enhances regulatory efficiency and reduces the time and costs associated with bringing new drugs to market.

Expected benefits of this integration include:

  • Enhanced Regulatory Review Processes: The combined solution will enable regulators to access critical data more efficiently, leading to faster review cycles and more timely approvals.
  • Improved Data Transparency: Sponsors and regulatory agencies will benefit from a unified platform that provides real-time insights into submission status, compliance metrics, and review outcomes.
  • Streamlined Workflows: By reducing manual processes and automating key regulatory functions, the integration will help sponsors navigate the complex approval process with greater ease and confidence.

Industry Impact and Market Implications

The life sciences industry is experiencing an increasing demand for more efficient regulatory processes. The integration of DNAnexus TRS with Veeva RIM is expected to address several longstanding challenges in the regulatory landscape, including:

  • Global Regulatory Harmonization: By creating a standardized platform for regulatory collaboration, the partnership will help align regulatory requirements across different regions, reducing inconsistencies and simplifying compliance efforts for sponsors.
  • Cost Savings for Pharmaceutical Companies: The ability to share data seamlessly between sponsors and agencies will help reduce administrative burdens and lower the costs associated with regulatory submissions.
  • Acceleration of Drug Development Timelines: Faster regulatory review processes mean that life-saving therapies can reach patients more quickly, ultimately benefiting public health on a global scale.

Statements from Industry Leaders

Executives from both DNAnexus and Veeva have expressed strong support for the expanded partnership and its potential to transform regulatory collaboration.

“Our partnership with Veeva marks a transformative step in regulatory innovation,” said Thomas Laur, CEO of DNAnexus. “Together, we will establish new ways for regulatory collaboration that empower organizations navigating complex and changing global requirements to advance the development and review of submissions in the cloud.”

Marc Gabriel, Vice President of Regulatory at Veeva, echoed these sentiments, stating, “Veeva looks forward to working with sponsors and partners, such as DNAnexus, to drive efficiencies in the delivery and review of health authority submissions to advance the industry.”

Early Access and Upcoming Demonstrations

DNAnexus plans to provide early access to the TRS platform in 2025, allowing select industry stakeholders to experience the benefits of the integrated solution firsthand. To showcase the capabilities of the TRS and Veeva RIM integration, DNAnexus will conduct live demonstrations at the following industry events:

  • DIA RSIDM: February 3–5, 2025 (Rockville, MD)
  • DIA Global 2025: June 15–19, 2025 (Washington, DC)

These events will provide regulatory professionals with an opportunity to explore the functionalities of the integrated platform and learn how it can enhance their regulatory workflows.

Source Link

Newsletter Updates

Enter your email address below and subscribe to our newsletter