Latest Developments and Insights

Understanding the intricacies of navigating regulatory affairs for clinical trials is pivotal in shaping the path to successful medical research and innovation. These regulations form the backbone of ensuring that your trials are not only compliant but also set up…

In the rapidly evolving pharmaceutical industry, the quality and safety of drug substances and products hinge significantly on the integrity of raw materials used in their manufacture. A risk-based approach to raw material testing and specification setting has emerged as…

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…