Blog Post

Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline

To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality...

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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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