Regulatory

AI has emerged as a transformative force in drug development, promising to revolutionize how new therapies are discovered, tested, and brought to market. AI technologies are revolutionizing the pharmaceutical landscape. From hastening identification of potential drug candidates, to optimizing clinical trial designs and post-market surveillance – AI technologies are revolutionizing pharmaceutical innovation. AI technologies allow […]

Drug shortages are an escalating global challenge, threatening the effectiveness of healthcare systems worldwide. These shortages occur when the supply of medications—ranging from critical life-saving drugs to essential treatments—falls short of the demand. While drug shortages have long existed, recent events such as pandemics, geopolitical conflicts, and natural disasters have highlighted the fragility of global

Africa’s healthcare and regulatory landscape have transformed to reflect the commitment of the continent to improve public health and ensure the safety and efficacy of medical products. Understanding this evolution is important for pharmaceutical manufacturing firms and professionals seeking regulatory services to navigate the African market efficiently. Historical Context The history of health in Africa is

Quality by design is a systematic approach to pharmaceutical development that begins with a predetermined objective and emphasizes product and process understanding and process control based on science and quality risk management. This method is redesigned to improve drug safety, efficacy, and overall quality by systematically identifying and managing critical quality attributes (CQAs) and critical

Vaccines are among the greatest achievements of modern medicine, safeguarding millions from infectious diseases. With the rapid evolution of global healthcare needs, particularly during pandemics, vaccine regulations have become more critical than ever. Both the United States and the European Union (EU) maintain stringent frameworks to ensure the safety, efficacy, and availability of vaccines. While

The rise of messenger RNA (mRNA) technology has transformed the pharmaceutical industry, as shown by its recent creation and use during the COVID-19 pandemic. mRNA therapeutics use synthetic RNA molecules to direct cells to make specific proteins that can prevent or treat illness, unlike conventional drugs that deliver protein directly to the body. mRNA serves

In the dynamic world of pharmaceuticals, biosimilars are reshaping treatment paradigms, offering cost-effective alternatives to biologic therapies while maintaining high-quality standards. The successful development and commercialization of biosimilars hinge on navigating complex regulatory pathways. This guide provides an in-depth look into the regulatory frameworks governing biosimilars in the European Union (EU) and the United States

The Asia-Pacific (APAC) region is a rapidly growing hub for pharmaceutical innovation and generic drug development. The increase in demand for generic drugs is due to their low cost and equivalent safety and efficacy to branded drugs. The APAC region incorporates a wide range of regulatory frameworks, from highly developed frameworks of stringent regulatory authorities