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By - Kossi Molley (he/il)

Predictive Analytics for Determining Non-Conformities in Pharmaceuticals

Predictive analytics applied to determining non-conformities in the pharmaceutical industry represents a significant advancement in ensuring product quality and safety. Here’s a detailed analysis of this field: 1. Importance of Predictive Analytics in Pharmaceuticals 2. Predictive Analytics Methods 3. Specific Applications 4. Challenges and Considerations In conclusion, predictive analytics offers significant potential to improve quality,

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By - Kossi Molley (he/il)

Understanding Health Canada’s New Draft GMP Guide for Natural Health Products

Health Canada has released a new Draft Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs), marking a significant update in the regulation of supplements, herbal remedies, vitamins, and other natural health products in Canada. If you’re a manufacturer, distributor, or consumer of NHPs, this draft guide is worth paying attention to—it could shape

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By - Kossi Molley (he/il)

Optimizing Quality and Compliance in Biopharmaceutical Projects

The biopharmaceutical industry operates within a complex web of regulatory requirements, demanding meticulous attention to quality and compliance at every stage of a project. From early-stage research to commercial manufacturing, deviations can have significant consequences, impacting patient safety, product efficacy, and the company’s reputation. Optimizing quality and compliance is not merely about ticking boxes; it’s a strategic imperative that drives efficiency, reduces risks, and fosters innovation.

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By - Kossi Molley (he/il)

White Paper: Decoding the Regulatory Maze for Biotech Innovation

In today’s rapidly evolving biotechnology landscape, regulatory challenges often determine the difference between groundbreaking innovations that reach patients and those that remain trapped in development limbo. We’re excited to announce the release of our comprehensive white paper, “Navigating the Regulatory Landscape: 10 Critical Challenges for Biotech Companies,” designed to help innovators chart a successful course

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By - Kossi Molley (he/il)

Navigating the Complex Landscape of CSV and CSA

Understanding and navigating the complexities of these frameworks is essential for organizations seeking efficiency, innovation, and regulatory alignment.

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