by Frank Sorce | Aug 25, 2016 | Blog, Medical Writing
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...
by Syner-G | Mar 10, 2016 | Blog, Medical Writing
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...
by Frank Sorce | Feb 25, 2016 | Blog, Medical Writing, Tim Garver
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...