COMPANY
Driving Innovation in the Life Sciences-Regulatory Ecosystem
We’re a nonprofit technology organization, modernizing regulatory interactions for the benefit of patients globally. We are committed to doing our part to help bring therapies to those in need faster than ever before.
WHAT WE DO
We are transforming how information flows between industry and regulators.
Instead of traditional paper-based processes and static documents, think instant communication, real-time data exchange, dynamic insights.
That is what our cloud-based platform offers. We are powering a new era of regulatory connectivity.
Envision a
future where:
- Patients around the globe receive safe and effective medicines faster and more efficiently than in today's environment
- The same life-changing therapies become available to all citizens at the same time regardless of geography
- Collaborations like the development of the COVID-19 vaccines become the norm, instead of the exception
Accumulus synergy is working to turn this vision into a reality
CASE STUDY
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
WHY ACCUMULUS
What Makes Us Different
Nonprofit
We’re a nonprofit technology organization founded to foster industry consensus and deliver cutting-edge, cloud-based technology. We aim to accelerate patient access to new therapies by leveraging innovative technology to keep regulatory processes on pace with 21st-century medicine.
Changemakers
We’re powering a new era of regulatory connectivity by working on behalf of – and across – the broader ecosystem including life sciences organizations (LSOs), national regulatory authorities (NRAs), non-government organizations (NGOs), and nonprofits – all in the service of patients.
Technology Developers
With our powerful, cloud-based platform, we’re pushing the boundaries of what’s possible, allowing for secure, regulatory collaboration and information exchange on an international scale.
Regulatory Influencers
Thanks to our team’s deep regulatory expertise, we’re well-positioned to engage with regulators to help shape policies and priorities that favorably impact public health. We focus on broadening stakeholder engagements worldwide to develop and deepen regulatory relationships.