February 29, 2024 | Evan DuBose, PhD and Kelsey Gray, PhD – Clinical Research Scientists | Medical Writing Services Does scheduling meetings feel like a circus act between juggling multiple calendars and balancing competing priorities? If so, you will likely...
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 submitted to...
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 CDMO partner remains one of the...
Our team of medical writers has worked with many clients on marketing applications (e.g., NDA, BLA, or MAA) across a variety of therapeutic areas. Each submission is a challenge in its own unique way, but we have found that the most exciting projects to work on are...
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 project. Regulatory medical writers...
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...
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