Uncategorized

Nancy Smith Senior Vice President, Medical Writing Services After I completed my PhD (in biomedicine with a focus on immunology), I was solidly entrenched in academia as a post-doctoral scientist at the Duke Human Vaccine Institute. While the rapidly evolving…

In the evolving healthcare landscape, medical writing in clinical research is a critical mainstay, seamlessly translating complex scientific discoveries into accessible, regulatory-compliant documents. This unique blend of science and communication allows breakthroughs in medical research to navigate the rigorous path…

The intricacies of medical writing vs. regulatory affairs reveal an intersection of science, communication, and law, pivotal to the healthcare industry’s backbone. At its core, medical writing focuses on crafting well-researched, clear, and concise documents related to drugs, devices, and…

Biopharmaceutical development is an extensive and complex process. Managing processes like Investigational New Drug (IND) applications or the manufacturing, quality, and regulatory side of the processes—collectively known as CMC, or the Chemistry, Manufacturing and Controls—requires a highly skilled team with…

Bringing a new drug to market is a complex process that can take years with no guarantee of a successful outcome. The journey is highly regulated and includes numerous processes that require drug developers to have multiple levels of expertise…

Drug development is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule from discovery to commercialization. Drug repurposing, also known as drug repositioning paves an alternate path for drug development which…