by Nancy Gasper Smith | Jan 16, 2024 | Blog, Medical Writing
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...
by Nancy Gasper Smith | Jan 10, 2024 | Blog, Medical Writing
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...
by Frank Sorce | Jun 2, 2020 | Blog, Kathryn Tworkoski, Medical Writing, Regulatory Operations
June 2, 2020 | Kathryn Tworkoski, PhD, RAC | Principal Clinical Research Scientist In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of...
by Frank Sorce | Oct 30, 2019 | Blog, Brandi Schuster, Medical Writing
October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services So you’ve decided to begin a career in medical writing – congratulations! Now what? It may be scary leaving the comfort of your lab and pipettes, and medical writing...
by Frank Sorce | Dec 14, 2018 | Blog, Drug Development Consulting, Kathryn Tworkoski, Medical Writing, Regulatory Affairs
December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist │ Regulatory Affairs, Medical Writing, Drug Development Consulting Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases,...
by Frank Sorce | May 15, 2018 | Blog, Medical Writing, Nancy Smith
May 15, 2018 | Nancy Gasper-Smith, PhD, RAC, Consultant, Medical Writing and Submissions Management and Head of Quality Control │ Medical Writing Services Quality control (QC) is a term that applies across many industries. Within the field of regulatory medical...