Enhanced Clinical Pathways: Mastering Challenges with Comprehensive Expertise & Emergency Management

Published on: May 20th, 2025

An emerging biotech had developed a gene therapy product for rare diseases. When navigating their IND application process, they faced several critical hurdles with very tight timeline available to address. VCLS stepped in to become a proactive and seamless extension of their team to manage the emergency of addressing unexpected FDA queries out of the usual working hours and to conduct associated operational activities, making sure they align with relevant guidance.

Learn more on how we ensured the client’s success.