Amgen & Accumulus Revolutionize Regulatory Submissions With First Digital CMC Dossier

Accumulus Synergy achieved a milestone by making history by powering Amgen’s first-ever digital Chemistry Manufacturing and Controls (CMC) Post Approval Change (PAC) dossier submission, which simultaneously reached both the Reference Country and twenty-one Reliance countries. The breakthrough aims to transform regulatory management through faster global approval processes and marks a new standard for transparent operational excellence. 

Francisco Nogueira, CEO of Accumulus, said in a statement, “For the first time ever, sponsors are able to submit a single, digital, global dossier to multiple regulators around the world with just a click of a button. The Accumulus platform isn’t just a technological advancement, it’s a reimagining of regulatory processes which could ultimately lead to patients receiving the treatments they need sooner.”

He also said, “As Accumulus continues to lead the charge in global regulatory transformation, it remains committed to creating a faster, more transparent, and collaborative future. We’re not just talking about the future of regulatory submissions; we’re actively creating it. Our Platform is reshaping how information is shared, how regulators and industry collaborate, and how approval timelines are accelerated, all with an unwavering commitment to the highest standards of compliance and security.”  

The Accumulus platform enables Amgen to create AI-driven written submissions using its proprietary SCDM software as regulators from the Reliance Reference Country, along with all participating regulatory authorities, conduct a parallel review of the dossier. The system provides all regulatory content in real-time to participating jurisdictions so they receive submission information, including ongoing answers and updates as new data appears. Full transparency between regulators can quicken review procedure durations while building a foundation for a completely digital regulatory operational system.  

“As a company dedicated to innovation, this is a proud moment for Amgen. Simultaneous regulatory submissions through the cloud could lead to faster reviews, approvals, and accelerated access to medicines for patients who need new treatment solutions. Using Amgen’s proprietary AI and SCDM software, we are looking forward to the next step in the industry’s digital evolution. By moving to cloud-based digital dossiers, we’re unlocking the true potential of digital transformation in regulatory collaboration. Democratized access to information ensures that every country, regardless of its role in the Reliance process, has the tools and data needed to drive faster decisions,” said Mark Taisey, Senior Vice President of Global Regulatory Affairs at Amgen

The submission by Accumulus, together with Amgen, has successfully established a crucial platform for transforming current Reliance management methods. In contrast to the typical Reliance project method, regulators typically depend on the completion of the Reference Country review to obtain specific data. Amgen chooses to use the Accumulus platform to share critical data simultaneously with all participating regulators and stakeholders.

The Accumulus platform and Reliance protocols with digital innovation capabilities from Accumulus partner with Amgen to decrease regulatory variations originating from time-consuming applications and different regulatory needs, which represent major global filing challenges. The method seeks to reduce review periods while regaining sponsor facility capacity in order to speed up medical treatment delivery worldwide.