BURLINGAME, Calif., Feb. 05, 2025 (GLOBE NEWSWIRE) -- In an industry-defining moment, Accumulus Synergy (“Accumulus”) has powered Amgen’s groundbreaking 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 transformative achievement aims to redefine the regulatory landscape by accelerating global approvals while setting a new benchmark for transparency and efficiency.

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Accumulus Synergy Powers Industry’s First Digitally Generated Dossier to Nearly Two Dozen Countries Simultaneously