Live Webinar: How to Fast-Track Innovation While Addressing CMC Challenges in Expedited Approval Pathways

Accelerated pathways from global agencies like the FDA, MHRA, and EMA help meet unmet medical needs and improve treatments.

Yet, compressed timelines and resource constraints pose unique challenges, ranging from limited API supply to clinical trial logistics. 

In Quotient Sciences' presentation, we explore several  different approaches for accelerated development which can be strategically used to meet requirements for expedited review pathways while mitigating CMC risks.

Our speaker will explore the critical role of expedited review pathways in accelerating the development and approval of new therapies. Attendees will learn about the various regulatory designations and how differing strategies for flexibility in early phases and clinical supply delivery through to commercialization may be leveraged to bring innovative treatments to market swiftly, while continuing to meet product quality needs and requirements for patient safety.. We will address real case studies and the relationships that Quotient Sciences has built with our clients as a trusted CRDMO outsourcing partner to navigate accelerated pathways effectively to meet urgent healthcare needs.

Key takeaways

• Understand the different expedited review pathways, their requirements, and strategic considerations for leveraging these in drug development
• Identify CMC challenges and solutions in managing compressed development timelines
• Gain insights into real-world applications and success stories of expedited pathways