Pharmaceutical Quality (Industry) Data Standard Publication White Paper
In an effort to enhance both collaboration and information exchange, Accumulus Synergy (“Accumulus”) sponsored an initiative with leading biopharmaceutical experts to develop the international standard for PQ (Industry) data…
Continue ReadingAccumulus Synergy Cloud Platform Shows ‘The Art of The Possible’
Never before have humans been so readily connected. And while global connectivity is great for staying in touch with friends or family or working from home, it also allows for profound jumps in innovation resulting from data exchange, global collaboration, and much more.
Towards the “Dossier In The Cloud” to Democratize Global Access to Medicines
Conversation with Accumulus Synergy CEO Francisco Nogueira.
In February 2024, the nonprofit industry association Accumulus Synergy announced the launch of its initial cloud-based information and data exchange platform through a regulatory reliance pilot project.
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.
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 ReadingIntroduction 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.
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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