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regulatory framework for cell, tissue, and gene therapy products

Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products

Insights, Regulatory /

Cell, tissue, or gene therapy products (CTGTPs) can contain non-viable or viable human cells or tissues, viable animal cells or tissues, or recombinant nucleic acids and are intended for use in humans to treat, prevent, or even diagnosis conditions that are associated with high treatment burden [1]. However, regulations surrounding CTGTPs vary per region as […]

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Transformation in Pharmacovigilance

Technological Transformation in Pharmacovigilance

Insights, Pharmacovigilance /

Technological disruption is rapidly occurring across all industries. In the pharmaceutical industry, technological contenders are gradually transforming the landscape of drug development, clinical trials, and pre-clinical phases. Indeed, this holds true for Transformation Pharmacovigilance and drug safety monitoring. Though the area of the industry is niche and highly regulated, hence the apprehension in incorporating technology

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Nanobodies vs Antibodies

Nanobodies vs Antibodies in the Fight Against Covid

Insights, Medical Writing /

Nanobodies are engineered small proteins that recognize and specifically bind to an antigen to initiate an appropriate signal- like antibodies. However, nanobodies bind to antigens with greater specificity and display other advantages over conventional antibodies. Extracted from camelids, these antibodies were found to comprise only of heavy chains, while demonstrating the same functions as conventional

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ai in drug discovery process

Enhancing Drug Discovery Process Through Artificial Intelligence

Insights, Medical Writing /

From pre-clinical phases to post-marketing follow-up studies, the drug development process is a challenging, expensive, and time-consuming process that can take many years to complete. Companies spend millions of dollars and countless hours to test the effectiveness of their new drugs. To save cost and time, pharmaceutical companies are incorporating ai in drug discovery process

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Impact of Russia Ukraine war on clinical Trails

The impact of the Russia-Ukraine war on clinical trials

Insights, Regulatory /

The Russia-Ukraine war has undoubtedly affected millions of people in and around the world. Several industries have taken a huge hit where operational and business continuity has been threatened, the pharmaceutical industry being one of them. From the delays along the drug development pipeline, to non-compliance products in the market being at risk, the industry

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WHO Global Centre For Traditional Medicine in Gujurat, India

The First WHO Global Centre For Traditional Medicine in Gujurat, India

Insights, Pharmacovigilance /

The 7th of April 2022 marked the 74th anniversary of the founding of WHO in 1948 which is celebrated annually as ‘World Health Day’. Each year draws attention to a specific health topic of concern to people all over the world. The onset of the pandemic has created history and has affected billions of people

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DDReg RegTech space

DDReg’s RegTech space: your regulatory solution for achieving rapid market access

Insights, Regulatory /

DDreg RegTech focuses on technologies that may facilitate the delivery of regulatory requirements more efficiently and effectively than existing capabilities. The global adoption of RegTech is a result of increased regulatory scrutiny, compliance costs, development of artificial intelligence, evolution of data science and increasing demands regarding cost-effective compliance solutions. With ever changing regulatory requirements, pharmaceutical

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Biologics development

Biologics development & regulatory approval – EMA perspective

Insights, Regulatory /

Biologics development in Biologic medicinal products, particularly biosimilars, has revolutionized the treatment of chronic conditions. As biologic products lose patent protection, biosimilars emerge as more readily accessible treatment alternatives. In the European Union (EU), the European Medicines Agency (EMA) is responsible for product approval. The EMA was the first regulatory authority to establish a regulatory

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biosimilars in MENA region

Biosimilarity and Interchangeability in the MENA region

Insights, Regulatory /

A biological drug (or Biosimilar) is one that is produced from a living organism or contains components of a living organism. They have become indispensable tools in modern medicine, for the treatment of life-threatening conditions. With an aging population and a growing demand for treating chronic conditions, biologic use is on the rise. However, they

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