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.
Continue ReadingDigital Transformation is Much More Than a Noun: Act Today for Modern Collaboration Tomorrow
Transformation is defined in the Cambridge Dictionary as “the process of changing completely the character or appearance of something in order to improve it.” This definition will also tell you that transformation is a noun — but it is much more.
Continue ReadingAccumulus Synergy: modernizing interactions with and among regulators
Biopharmaceutical companies push the boundaries of science to develop medicines, employ the most sophisticated techniques to visualize and analyze data, and then painstakingly transfer the results onto paper or PDFs to communicate data to regulators.
Continue ReadingThe Future of CMC Regulatory Submissions- Streamlining Activities Using Structured Content and Data Management
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Continue ReadingTransitioning Chemistry, Manufacturing, and Controls Content With a Structured Data Management Solution- Streamlining Regulatory Submissions
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Continue ReadingRe-Envisioning Pharmaceutical Manufacturing- Increasing Agility for Global Patient Access
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