Latest Developments and Insights

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 Gene Therapy Products, which supported a phase appropriate approach…

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…

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…

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…

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…

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 translating…