Author name: development

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

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

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

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