Category Archives: White Papers & Publications

Unleashing the Power of Reliance for Post-Approval Changes with 48 NRAs

Post-approval changes (PACs) are an essential part of product lifecycle management to ensure continuous supply of life-saving medicines in case of increased demand, to support continuous improvement and optimization of the manufacturing process, to remain state-of-the-art with analytical techniques, and to ensure continuity to comply with the updated regulatory requirements. 

Walking the talk in digital transformation of regulatory review

Cloud-based regulatory platforms have the potential to substantially transform how regulatory submissions are developed, transmitted, and reviewed across the full life cycle of drug development. The benefits of cloud-based submission and review include accelerating critical therapies to patients in need globally and efficiency gains for both drug developers and regulators.

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Introduction to Accumulus Synergy

We are developing a global information exchange platform to transform how drug innovators and health regulators interact to bring safe and effective medicines to patients faster and more efficiently.

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