Meet the Experts Behind the Marketing Application Readiness Webinar

Thank you for tuning in to our webinar, How to Prepare for a Successful Marketing Application Submission .

Every development program faces unique regulatory challenges. Whether you’re preparing for an upcoming marketing application, evaluating submission readiness, or navigating evolving global requirements, our regulatory experts are here to help.
 
Continue the conversation with the speakers from How to Prepare for a Successful Marketing Application Submission. With decades of combined experience across regulatory strategy and operations, they partner with sponsors to identify potential risks early, streamline submission planning, and help programs move toward approval with confidence.
 

Whether your team is preparing for an upcoming submission or looking to strengthen its regulatory strategy, we’re here to discuss challenges such as:

  • Assessing marketing application readiness
  • Identifying and addressing submission gaps
  • Preparing for FDA meetings and health authority interactions
  • Navigating regional regulatory requirements and eCTD expectations
  • Strengthening submission planning and operational execution

Meet The Experts

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

Elizabeth Narciso – Vice President,
Regulatory Operations

Let’s discuss your goals and explore strategies tailored to your development pathway. Complete the form to have your questions answered by our experts.

Schedule A Meeting

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