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New Revolution with Multimedia and eConsent

Revolutionizing Informed Consent: Are Multimedia and eConsent the New Norm? 

All Category, Blogs, Clinical Regulatory, regulatory /

Informed consent is a critical part of ethical clinical research, designed to ensure participants fully understand the nature, risks, and benefits of a trial before enrolling. However, for years, traditional paper-based consent processes have fallen short. Dense language, static formatting, and lack of personalization have made it difficult for many participants to grasp what they […]

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Complete Guide to the Egypt Medical Device Registration Process

How to Register a Medical Device in Egypt: Regulatory Pathways with the EDA 

All Category, Blogs, regulatory /

Egypt is fast emerging as a strategic healthcare hub in the MENA region, with a growing market for medical devices. For manufacturers looking to access this market, understanding the regulatory framework laid down by the Egyptian Drug Authority (EDA) is critical. Unlike the traditional pharmaceutical landscape, medical device registration in Egypt is governed by its

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AI-Powered Regulatory Submissions in 2025

AI-Powered Regulatory Submissions: A New Era for IND, NDA, & BLA Documentation 

All Category, Blogs, regulatory /

Regulatory submissions have always been the linchpin of drug development. From paper-based dossiers to the globally adopted electronic Common Technical Document (eCTD), the journey of regulatory documentation has continuously evolved. However, as life sciences companies contend with increasing data volumes, complex global regulatory requirements, and pressure to accelerate time-to-market, even eCTD processes are showing their

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Types of vigilance in life science industry

Types of Vigilance Every Life Sciences Professional Should Know 

All Category, Blogs, Pharmacovigilance, regulatory /

In the global life sciences industry, whether you’re launching a new pharmaceutical, a medical device, or a personal care product, the responsibility doesn’t end at regulatory approval. It extends across the product lifecycle, driven by a commitment to patient and consumer safety, and reinforced by an evolving web of global regulatory requirements.    Traditionally associated

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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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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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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 

All Category, Blogs, regulatory /

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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