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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)

Ensuring Drug Safety

In the dynamic world of pharmaceuticals, ensuring patient safety is paramount. Pharmacovigilance, the science and activities relating to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problem, plays a critical role in this endeavor. Mivado GlobalPerformance Inc. is a leading provider of comprehensive pharmacovigilance solutions, helping pharmaceutical companies navigate the complexities of

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By - Kossi Molley (he/il)

Rethinking Quality Processes in the AI Environment

Artificial intelligence (AI) rapidly transforms the biopharmaceutical industry, offering unprecedented opportunities to enhance efficiency, accuracy, and innovation. However, as AI becomes increasingly integrated into GMP-regulated processes, traditional quality management approaches must be rethought. This article delves into the critical aspects of GMP quality compliance in the AI era. It explores the top five reasons why

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By - Kossi Molley (he/il)

Cross-Contamination in Biopharmaceutical : A Quality Perspective

In the biopharmaceutical industry, cross-contamination is a significant concern, with potential impacts on product safety, efficacy, and ultimately, patient health. Cross-contamination occurs when trace amounts of one product inadvertently mix with another product, equipment, or process stream. This can lead to compromised product integrity, regulatory non-compliance, and costly recalls. From a quality assurance (QA) perspective,

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By - Kossi Molley (he/il)

Impact of Validation by Design in Biopharma

What should we expect from Validation 4.0 Validation by design a.k.a Validation 4.0 is a new approach to validation in the biopharmaceutical industry that is designed to be more efficient, effective, and compliant with regulatory requirements. It is based on the principles of risk-based thinking, quality by design, and data integrity by design.   Key

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