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Accumulus Synergy

Burlingame, California, United Statesaccumulus.org ↗

Ownership: Private
Development stage: Commercial

Overview

Successfully enabled the largest Post Approval Change Reliance Pilot with 48 regulators across six continents, reducing global approval time from ~2.5 years to 6.5 months. Powered Amgen’s first-ever digitally generated CMC PAC dossier submission to nearly two dozen countries simultaneously in early 2025. The company’s cloud-based regulatory information exchange has demonstrated significant reduction in approval timelines and improved transparency for global drug submissions through high-profile pilots with major pharmaceutical companies like Amgen.

Industry: Biomedical IT and Biomedical Data Platforms

Partnerships

AmgenAstellasAstraZenecaBristol Myers SquibbGSKJohnson & JohnsonEli Lilly and Co.MerckPfizerRocheSanofiTakeda

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