10 Feb Accumulus Synergy powers industry’s first digitally generated dossier to nearly two dozen countries simultaneously

Accumulus Synergy has powered Amgen’s regulatory submission: the first-ever, digitally generated Chemistry, Manufacturing, and Controls (CMC) Post Approval Change (PAC) dossier, delivered to the Reference Country and nearly two dozen participating Reliance countries, simultaneously.

This aims to redefine the regulatory landscape by accelerating global approvals while setting a new benchmark for transparency and efficiency.

Leveraging the Accumulus platform, the digitally generated dossier created by Amgen using its proprietary AI and novel Structured Content and Data Management (SCDM) software is being reviewed by the Reliance Reference Country and all participating regulators at the same time.

This means that every jurisdiction involved has real-time access to all regulatory information, from submission details to ongoing questions, answers, and updates, as it becomes available.

“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,” said Francisco Nogueira, CEO of Accumulus. “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.”

“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,” said Mark Taisey, Senior Vice President Global Regulatory Affairs, Amgen. “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.”

“As Accumulus continues to lead the charge in global regulatory transformation, it remains committed to creating a faster, more transparent, and collaborative future,” added Nogueira. “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.”