by David Malliaros | Apr 16, 2024 | Blog, Regulatory Affairs
16 Apr 2024 | Renee Boerner, Dave Malliaros, Norris Pyle One of the many challenges around developing cell and gene therapy products is establishing representative potency methods. In 2011, the FDA released the Guidance for Industry: Potency Tests for Cellular and...
by Nate DiTommaso | Apr 5, 2024 | Blog, Regulatory Affairs
05 Apr 2024 | Nate DiTommaso, Rachel Capone, Renee Boerner Have you ever wondered why some companies choose to do their first in human clinical trials in Australia? Are there any real advantages or are people just looking for an excuse to go to the ‘Land Down Under,’...
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...