Author name: development

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

Regenerative medicine is a field that has emerged as a new component of modern medicine/healthcare by introducing therapies that repair or replace damaged tissues and organs through innovative approaches, including stem cells, gene therapy, and extracellular vesicles. Having the potential to address medical needs, regenerative medicine also presents unique regulatory challenges given the lack of

A pharmaceutical product’s journey through its development lifecycle, all the way to commercialization stage, is relatively complex. What adds more to the complexity is the labyrinth of regulatory requirements, which vary from region to region. Therefore, pharmaceutical companies that want to introduce their innovative therapies face several obstacles as they navigate through the regulatory intricacies