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GMP compliance for advanced therapies and biologics

GMP Compliance in the Era of Advanced Therapies and Biologics

All Category, Blogs, regulatory /

The global biopharmaceutical industry is undergoing a transformative shift as advanced therapy medicinal products (ATMPs) including gene therapies, somatic cell therapies, and tissue-engineered products and complex biologics become central to innovation pipelines. According to a Report by ARM, as of Q2 2025, there are over 1,900 active CGT clinical trials, 2,070 developers, and $5.0 billion in […]

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Evolution of EU drug safety reporting tools

Evolving Safety Reporting in the EU: Beyond EudraVigilance to EVDAS & SPOR 

All Category, Blogs, Pharmacovigilance /

With safety reporting in the European Union (EU) entering a new era of digital integration and oversight, pharmacovigilance systems have become more connected, data-driven, and strategically central to regulatory compliance. What once revolved around manual case handling and isolated national databases has transformed into a highly interconnected pharmacovigilance network. This shift is not only redefining

Evolving Safety Reporting in the EU: Beyond EudraVigilance to EVDAS & SPOR  Read More »

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

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

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

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

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

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

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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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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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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