How to Prepare for a Successful Marketing Application Submission 

July 14th, 2026
11 a.m. EDT

As biotech and pharmaceutical companies advance innovative therapies toward commercialization, preparing for a successful marketing application submission has never been more critical. Regulatory expectations continue to evolve across regions, and even minor gaps in submission readiness can lead to costly delays or a refuse-to-file outcome. Early assessment and proactive planning are essential to de-risk the submission process and streamline approval pathways.

In this webinar, experts in regulatory strategy and operations will discuss how sponsors can assess marketing application readiness throughout the later stages of drug development, including pivotal trial planning, execution, and submission preparation. Attendees will gain insights into identifying and addressing potential gaps in critical data across chemistry, manufacturing and controls (CMC), nonclinical, clinical, and geography-specific regulatory requirements. The session will also highlight key regulatory agency interactions and operational strategies to help streamline submission execution.

Join us to learn practical approaches for building submission confidence, reducing regulatory risk, and positioning your program for a smoother path to market approval.

Attendees will gain insights into:

• Assessing marketing application approval readiness 
• Identifying gaps and developing remediation plans to reduce delays 
• Navigating regional regulatory differences, including eCTD updates  

Speakers:

Cathy Gatza, Ph.D. – Vice President, Regulatory Strategy

Elizabeth Narciso – Vice President, Regulatory Operations