Blog Post
Biotech’s Compliance Odyssey: Navigating the Revamped EU GMP Annex 1 in the Age of Innovation and Accountability
In the dynamic world of biotechnology, where innovation is moving at a rapid pace and patient safety is paramount, compliance with regulatory standards is non-negotiable....
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Blog Post
Revolutionizing Drug Manufacturing: A closer look at pending Facility Applications for GMP Inspections
COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. Whilst certain aspects of the pandemic have gone away,...
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Blog Post
Moving the Goalposts?
Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management? (more…)
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Blog Post
Are You Ready? Major Changes Coming to Europe MDR and IVDR
Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the...
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