Latest Developments and Insights

  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…

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…

  The IND Filing Process and Categories Federal law mandates that drugs have an approved marketing application for interstate transport, but developers of new drugs must distribute their potential products nationwide in order to conduct clinical trials, and so must…

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…