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 Olivia Rivera, PhD | Mar 28, 2024 | Blog, Medical Writing
28 March 2024 | Olivia Rivera, PhD and Yael-Natalie H Escobar, PhD When COVID-19 shut down workplaces, remote work became the norm for many, including medical writers. Now, in a post-pandemic world, many medical writers continue working from home, finding their daily...
by Christina (Chrissy) Williams | Mar 25, 2024 | Blog, Medical Writing
25 Mar 2024 │ Christina (Chrissy) Williams, PhD, RAC, Sr Director │ Medical Writing Services How can we shorten the timeline? Clinical and regulatory medical writers often hear that question on repeat. There’s the obvious answer…provide on-time, high-quality, clean...
by Euan Griffiths | Mar 11, 2024 | Blog, Medical Writing
05 Mar 2024 │ Euan Griffiths, Senior Quality Control Specialist │ Medical Writing Services When we think of medical writing, style is not the first thing that springs to mind. It is, however, crucial to ensure quality and consistency within a document, as well as...
by Frank Sorce | Mar 6, 2024 | Blog, Medical Writing, Nancy Smith
Welcome to the essential yet often behind-the-scenes world of regulatory medical writing. This field stands at the crossroads of science and communication for the approval of new medical treatments. Regulatory writers are the linchpins in this process, tasked with...