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Regulatory oversight of companion apps

Regulatory Oversight of Companion Apps: Where Do They Stand? 

All Category, Blogs, Medical Device, regulatory /

Imagine sipping your morning coffee while an app effortlessly syncs with your glucose monitor. These are companion apps, digital tools that extend the functionality of medical devices. But with innovation comes responsibility. So, who ensures these apps are safe, effective, and secure?  Companion apps, particularly in healthcare, are rising fast. But the regulatory frameworks that […]

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Expanding to Japan’s Pharma Market? Here’s What You Need to Know

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Japan constitutes the world’s third-largest pharmaceutical market, presenting substantial opportunities for companies seeking to expand internationally. With a market size that achieved USD 82.27 billion in 2024 and a projected growth to USD 101.90 billion by 2033, Japan’s pharmaceutical landscape offers both considerable potential and distinct regulatory challenges. However, Japan’s pharmaceutical market is  governed by a

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ZaZiBoNa significance for pharmaceutical companies in SADC

What ZaZiBoNa Means for Pharma Companies Targeting the SADC Market 

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For pharmaceutical companies eyeing expansion into the Southern African region, understanding the regulatory processes of 16 different countries can be a costly, time-consuming, and resource-intensive endeavor. But what if there was a way to streamline this process reducing approval times, harmonizing requirements, and unlocking simultaneous market access across multiple nations? Enter ZaZiBoNa, a collaborative medicines

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QbD, RBQM, and RBM in Pharma and Clinical Research in 2025

Regulatory Perspectives on QbD, RBQM, and RBM in Pharma and Clinical Research 

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Why are pharma and clinical trial leaders doubling down on QbD, RBQM, and RBM in 2025? Because “compliance” is no longer enough, today, regulators expect quality, risk-awareness, and strategy to be embedded from the very beginning.  From decentralized trials to AI-driven insights, the pace of change is rapid—and so are the expectations from regulators like

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Artificial Intelligence (AI) in Life Sciences: Ethics, Regulatory Frameworks, and Governance for Responsible Innovation 

All Category, Blogs, regulatory /

The integration of Artificial Intelligence (AI) in the life sciences sector has ushered in a new era of innovation enabling precision drug discovery, streamlining clinical trial operations, automating regulatory workflows, and personalizing therapeutic interventions. However, as AI capabilities advance, so do the ethical concerns, regulatory scrutiny, and governance challenges surrounding its responsible deployment.  This article

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