WHAT WE DO
We connect the global regulatory ecosystem through a single, scalable solution.
The Accumulus platform is a cloud-based SaaS solution that instantly connects life sciences organizations and regulators across the globe. It brings together those who develop therapies with those who review and approve them in a way that improves the ease, speed, and flow of information.
Instead of traditional paper-based processes and static documents, think instant communication, real-time data/information exchange, and dynamic insights.
Envision a future where:
Accumulus Technologies is working to turn this vision into a reality
CASE STUDY | REGULATORY RELIANCE
Reducing Global Approval Time from 2.5 Years to 6.5 Months
With the launch of the first-in-kind Accumulus platform in February 2024, what was once considered simply visionary is now a reality.
Using the then newly launched Accumulus platform, a leading biopharmaceutical company led a Post Approval Change (PAC) Reliance project involving 48 regulators across six continents.
The pilot consisted of submitting questions and responses on a PAC submission, and to date, is the largest PAC Reliance Pilot ever conducted.
The overarching objective of the pilot was to increase predictability for the implementation of changes and reduce the complexity of global life-cycle management through Reliance1.
The Accumulus platform supported this objective by enabling user-initiated projects, NRA invitations, content upload, quality control, and health authority questions (HAQs) and answers.
Using the Accumulus platform, and a Reliance pathway guided by WHO best practices, the Accumulus platform enabled a reduced global approval time from approximately 2.5 years to 6.5 months (100-week reduction)1.
- 1. Mangia, F., Lin, Y. M., Armando, J., Dominguez, K., Rozhnova, V., & Ausborn, S. (2024). Unleashing the Power of Reliance for Post-Approval Changes: A Journey with 48 National Regulatory Authorities. Therapeutic innovation & regulatory science, 10.1007/s43441-024-00677-8. Advance online publication. https://doi.org/10.1007/s43441-024-00677-8
Our Story
2020
Formation and Foundation
Responding to a call to action, Accumulus Synergy is established as a nonprofit industry association to accelerate therapies to citizens of the world by developing a novel collaboration platform.
2021
Regulatory Engagement
To advance its mission, Accumulus Synergy begins engaging with national regulatory authorities across the globe.
2022
Growing Stronger
The industry association increases its life sciences sponsorship and begins staffing up a full-time workforce to accelerate the development the Accumulus platform.
2023
Expanding Reach
To help shape regulatory collaboration and information exchange, the Accumulus Synergy Regulator Forum stands up with representation from national regulatory authorities around the world.
2024
Platform Launch
The initial launch of the Accumulus platform powers the largest reliance submission to date, including 48 countries and resulting in a 100-week reduction in global approval time.
2025
Accumulus Technologies is Born
Responding to increased demand, Accumulus Synergy spins out Accumulus Technologies, a commercial technology company created to scale the Accumulus platform.
WHY ACCUMULUS TECHNOLOGIES
What Makes Us Different
Purpose-Built Technology
Our technology isn’t retrofitted—it’s purpose-built for regulatory connectivity. Originally incubated by Accumulus Synergy and launched in 2024, the Accumulus platform provides a secure, cloud-based digital environment where sponsors and regulators can engage in real time, share submissions simultaneously, and power modern regulatory approaches like reliance and work sharing.
Mission-driven Team
Every day matters when patients are waiting for life-changing therapies. That’s why we approach our work with a bias toward action, challenging legacy models and moving fast to deliver value. Our teams understand the human impact behind the mission—and we design our technology and services with that in mind.
Globally-Aligned Mindset
Our commitment to global harmonization starts with meaningful local engagement. We partner across geographies and maturity levels to connect regulators and life sciences organizations through a single, shared platform—advancing cross-border collaboration and accelerating access to therapies where they’re needed most.
Expert-Led Organization
Our company is led by the team that helped bring the Accumulus platform to life—experts with deep experience in life sciences, regulatory strategy, cybersecurity, and enterprise technology. Backed by proven governance and scalable architecture, we serve as a trusted enabler for organizations and agencies ready to modernize regulatory engagement at speed and scale.