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Role of Placebos in Clinical Trials for Medical Science

Placebos in Clinical Trials: A Fundamental Component of Medical Science 

All Category, Blogs, Clinical Regulatory /

Suppose you are taking a pill, fully aware or sometimes not aware that it contains no active ingredients and yet experiencing an improvement in your symptoms. While this may sound implausible, it illustrates the remarkable reality of the placebo effect an enduring phenomenon that has both puzzled and guided the medical community for centuries. In […]

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Current Trends in Advanced Therapies 2025

All Category, Blogs, regulatory /

Breakthroughs in biotechnology are transforming how we approach some of the most challenging medical conditions. Genetic disorders, late-stage cancers, and severe tissue damage are increasingly being treated with therapies tailored to each individual’s unique biology. From gene therapies that rewrite faulty DNA to cell-based treatments that regenerate damaged tissue, advanced therapies are not just reshaping

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Training Support on Process Validation Methods case study

Technical Upskilling through Expert Training Support on Validation Methods

All Category, Case Studies, Regulatory /

Customer Requirement A leading India-based pharmaceutical manufacturer with global operations sought to strengthen its internal technical capabilities related to Analytical Method Validation (AMV) and Process Validation (PV). With increasing regulatory scrutiny from agencies such as the FDA, EMA, and ICH, the company aimed to ensure compliance with current global guidelines while fostering cross-functional understanding across

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From Waste to Worth: Aligning Your Packaging Strategy with the EU PPWR

All Category, Blogs, regulatory /

Imagine a world where every pill bottle, blister pack, and shipping box not only protects life-saving medications but also safeguards our planet. The PPWR, officially designated as Regulation (EU) 2024/1781, replaces the previous Packaging and Packaging Waste Directive 94/62/EC with a more harmonized approach to packaging sustainability. The EU PPWR Regulation officially entered into force on

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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

All Category, Blogs, regulatory /

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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Automating Medical and Scientific Literature Monitoring for Drug Safety

Automation of Literature Monitoring for Pharmacovigilance

All Category, Blogs, Pharmacovigilance /

Literature monitoring, a key component of pharmacovigilance (PV), involves searching and analyzing medical and scientific publications, including journal articles, case reports, conference abstracts, and online content to identify reports of ADRs, safety signals, or other pertinent information. This surveillance is essential for detecting previously unknown adverse reactions or risks that may not have emerged during

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ZaZiBoNa significance for pharmaceutical companies in SADC

What ZaZiBoNa Means for Pharma Companies Targeting the SADC Market 

All Category, Blogs, regulatory /

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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