by Frank Sorce | Jan 10, 2022 | Blog, Regulatory Affairs
January 10, 2022 | Julia DiFiore, PhD | Clinical Research Scientist Many of us involved with drug development derive a lot of satisfaction in knowing that our work contributes to improving the health of patients around the globe. We offer our insight and expertise...
by Frank Sorce | Feb 25, 2019 | Blog, Cheryl Ainslie, Regulatory Affairs
February 25, 2019 | Cheryl Ainslie, PhD, Clinical Research Scientist II | Regulatory Affairs Services In a previous post, I summarized the process by which the International Council for Harmonisation (ICH) creates harmonized guidelines for use by the pharmaceutical...
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 | Apr 20, 2018 | Blog, Drug Development Consulting, Regulatory Affairs
April 20, 2018 | Kasturi Puranam, PhD | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting I hope that you have read our previous blog posts on IND filing and have learned about the types of INDs, when you need to file an IND, and pre-IND...
by Frank Sorce | Mar 14, 2018 | Blog, Drug Development Consulting, Regulatory Affairs
March 14, 2018 | Preeti Chugha, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting You’ve determined that you need to file an IND to conduct human trials in the US. What do you need to do before you submit your IND? While INDs...
by Frank Sorce | Feb 16, 2018 | Blog, Drug Development Consulting, Kathryn Tworkoski, Regulatory Affairs
February 16, 2018 | Kathryn Tworkoski, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting Introducing a new therapeutic agent to human patients can be simultaneously exciting and nerve-wracking. Over the years, we’ve had a lot...
