Case Studies: From Hurdles to Milestones: Accelerated Global IND/CTA Approvals

Leading a biotech start-up through a complex regulatory landscape

A start-up biotech company faced signifi cant hurdles in obtaining Investigational New Drug (IND) and Clinical Trial Application approvals to launch first-in-human clinical trials globally. Navigating the complexities of diverse regulatory landscapes and meeting stringent compliance requirements created substantial obstacles for the biotech company.