Medical Writing Services
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...
Record Numbers of FDA‑Approved Drugs: Recent Trends
March 10, 2016 | Kathryn Tworkoski, PhD, Clinical Research Scientist | Regulatory Affairs, Medical Writing Services, Drug Development Consulting Everyone knows that getting FDA approval of a new drug, whether it be a new molecular entity (NME) approved through a new...
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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