Generative Artificial Intelligence (Gen AI) has become a buzzword in the tech world, but its application goes far beyond creating content like text, images, and videos. While these creative applications are exciting, the real power of generative AI lies in its ability to generate entirely new data, models, and scientific insights transforming fields like life […]
Exploring the Future of Generative AI in Life Sciences Read More »
As global pharmaceutical companies intensify their focus on Asia-Pacific markets, Taiwan has emerged as a key strategic hub offering a stable regulatory environment, robust IP protection, and a high generic drug uptake under a universal healthcare system. Despite its relatively modest population, Taiwan punches above its weight in terms of healthcare spending and quality standards.
Taiwan Generic Drug Registration Process Read More »
Complementary and traditional health products are now subject to increasing regulatory oversight in South Africa, driven by SAHPRA’s evolving mandate. Once considered outside the formal regulatory scope, CTMs are now under increasing scrutiny by the South African Health Products Regulatory Authority (SAHPRA). This shift signals the government’s intent to ensure that all health-related products regardless
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
GMP Compliance in the Era of Advanced Therapies and Biologics Read More »
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 »
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 »
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 »
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
Types of Vigilance Every Life Sciences Professional Should Know Read More »
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
Current Trends in Advanced Therapies 2025 Read More »
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
From Waste to Worth: Aligning Your Packaging Strategy with the EU PPWR Read More »
