Latest Developments and Insights

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…

February 16, 2024 | Yash Patel, PharmD, Yamini Purohit, PhD, and Kelsey Gray, PhD – Medical Writing Fellows | Medical Writing Services   Regulatory medical writers play a key role in facilitating the development and compilation of documents that are…

Selecting a Contract Development and Marketing Organization (CDMO) is not a new topic, and much has been written and learned since CDMO’s first started to become an option in the late 1990s. If the decision is to outsource, selecting a…

  Our team of medical writers has worked with many clients on marketing applications (e.g., NDA, ANDA, BLA, or MAA) across a variety of therapeutic areas. Each submission is a challenge in its own unique way, but we have found…

  Whether it’s a clinical study report (CSR) for a single clinical study or a Clinical Overview that summarizes a complex clinical development program, it’s often best to consider who you’re writing for at the very start of a writing…

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…