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...
by Frank Sorce | Feb 10, 2016 | Blog, Drug Development Consulting, Gilbert “Chip” W. Carnathan, Regulatory Affairs
February 10, 2016 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting Yeah, yeah, we know. The general public considers biosimilars to be “generic” versions of approved biological products. The FDA has gone to...
by Frank Sorce | Aug 20, 2015 | Blog, Mark Cierpial, Regulatory Affairs
August 20, 2015 | Mark Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs We’ve all seen or heard them – either in popular magazines and newspapers or on television and radio – advertisements directed to us, the consumers of prescription...