Medical Writing Services
Keep ’em Coming: An Overview of IND Updates
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...
From Benchtop to Desktop: 8 Transferable Skills Learned in the Lab that Apply to 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 may...
Current Topics in Orphan Drug Development
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,...
The Why, What, When, Who, and How of Quality Control (QC) of Medical Writing Deliverables
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...
What Skills Do You Need to Be a Good Regulatory Medical Writer?
August 25, 2016 | Kim Nice, PhD, Associate Director, Medical Writing and Submissions Management | Medical Writing Services In previous posts, you were introduced to the role of regulatory medical writing and heard about the day-to-day activities of a regulatory...
What Does a Regulatory Medical Writer Do All Day?
August 11, 2016 | Nancy Smith, PhD, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services In my last post, I explored my transition from the bench to regulatory medical writing. I knew little about medical writing when I started, but...
Planning Your NDA or BLA Submission: It’s More Than a Gantt Chart!
February 25, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services You’re finally there! You and your colleagues find yourself at the doorstep of being able to submit either a New Drug Application (NDA) or Biologic License...
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