Welcome to Chasing Compliance, the GLOBAL regulatory podcast, where we discuss all aspects of medical device and pharmaceutical regulatory and clinical strategy – from bench to bedside.

Today we are chatting with Emily Stephens, the founder and CEO of GLOBAL. Emily worked in the medical device and biologics industries for thirteen years before launching GLOBAL in early 2014. After years of 60-hour work weeks for CROs that were notorious for burning out workers, she developed an autoimmune disease that would forever change her vision of the medical writing industry. Life was too short for burnout. She wondered: What would happen if there was a company that treated workers with respect, loyalty, and deeply advocated for their work/life balance? ‍Out of this question GLOBAL was born and the outcome has been spectacular: We attract the best, who then perform at their best, because this is a place where we fiercely take care of each other.

Thank you for being here, Em! On this episode, we are exploring 2026 – what are we looking forward to, what are we looking out for, and what opportunities exist. Let’s dive in!

Welcome to Chasing Compliance, the GLOBAL regulatory podcast, where we discuss all aspects of medical device and pharmaceutical regulatory and clinical strategy – from bench to bedside.

Today we are chatting with Violet Chazovachii. Violet has spent almost a decade in the biomedical technology field. As a graduate researcher at the University of Michigan Ann Arbor, she focused on developing surface coatings to optimize microparticles for vascular targeted drug delivery. After earning her master’s degree, she joined Global’s CER internship program in 2021 and has advanced to the role of Lead Medical Writer, where she continues to contribute to high-impact regulatory submissions. Violet recently earned her RAC (Regulatory Affairs Certification) in Medical Devices

Thank you for being here Violet! On this episode, we are discussing RAPS convergence 2025. We sent a team to this conference and had a wonderful experience connecting with regulatory affairs peers and learning the latest developments and trends in US and global healthcare regulations. Violet was one of our teammates on the ground and has some great insights from the week. Let’s dive in!

Welcome to Chasing Compliance, the GLOBAL regulatory podcast, where we discuss all aspects of medical device and pharmaceutical regulatory and clinical strategy – from bench to bedside.

Today we are chatting with Julie Matison and Scott Michaels.

Julie Matison holds a Bachelor’s degree in Chemical Engineering and a Master’s degree in Mechanical Engineering, and recently earned the RAC-Drugs certification through RAPS. She has over 21 years of experience in the pharmaceutical industry, with a strong background in manufacturing, validation and quality.

Scott Michaels earned his Master’s in Pharmaceutical Chemistry from the University of Kansas and his Bachelor’s in Chemistry from McGill University. He has held a variety of regulatory and CMC product development roles over the past 20 years, working with both small molecules and biologics.

Thank you both for being here! On this episode, we are discussing CMC strategy around biologics IND submissions. I am sure our audience is looking forward to your insights, so let’s dive in.