The Accumulus Platform Powers Sanofi's Submissions to Multiple Regulators Around the World

“The Accumulus platform introduces unprecedented scalability and is designed to unlock the full potential of reliance pathways and regulatory collaboration as a whole,” said Francisco Nogueira, CEO at Accumulus. “We're offering a solution that helps shorten cycle times, accelerate review and feedback, and increase equitable patient access on a global scale. We're not just making reliance pathways viable—we're making them scalable and operational.”

Sanofi's adoption of the Accumulus platform marks another move towards fit-for-purpose technology that ensures secure, real-time global regulatory connectivity. Many of the NRAs involved in the Sanofi submission are repeat users of the Accumulus platform, underscoring the Platform's capacity to meet the needs of industry and regulators alike.

“Sanofi has long been at the forefront of regulatory innovation as a founding member of Accumulus,” said Eddie Reilly, Chief Regulatory Officer, Head of Global Regulatory Affairs at Sanofi. “Today's regulatory landscape requires innovative solutions that can evolve with the increasing complexity and volume of submissions. With the Accumulus platform's unique capability to support multiple reliance submissions concurrently, we can now scale up our efforts in ways that were previously unattainable. This scalability allows us to accelerate the delivery of potential new treatments to patients, driving greater efficiency and impact.”

With numerous planned submissions underway for 2024, the Accumulus platform is setting a new standard for managing simultaneous submissions to multiple national regulatory authorities, paving the way for a much anticipated fully digital, single global dossier. 

"Our Platform is redefining how life sciences organizations manage regulatory submissions and interact with stakeholders to accelerate the delivery of life-saving treatments,” added Nogueira. “By bridging the gap between life sciences organizations, regulators, and external partners, the Accumulus platform is leading the way in the digital transformation, ensuring collaboration at scale to meet the growing demands of the global healthcare ecosystem. This is another key step towards the moonshot of a single dossier in the cloud.”

To learn more about Accumulus Synergy, visit www.accumulus.org.

About Accumulus Synergy
Accumulus Synergy is a global, nonprofit industry association developing a transformative data exchange platform that aims to enable enhanced collaboration and efficiency between life sciences organizations and global Regulatory Authorities while also affording users the ability to extract dynamic, data-driven insights. Accumulus is working with key stakeholders in the life sciences-regulatory ecosystem to build and sustain a platform that aims to meet regulatory, cybersecurity, and privacy requirements spanning clinical, safety, chemistry, and manufacturing and regulatory exchanges and submissions. Accumulus Synergy Sponsors include leading global pharmaceutical companies.

Media Contact
Allison Mari
[email protected]
540-907-6053