How to Avoid & Fix Common Mistakes in Regulatory Submissions

Streamlining regulatory submissions: avoiding common mistakes

Regulatory submissions are essential for gaining approvals and marketing new products in the pharmaceutical and biotechnology industries. However, this multi-layered process is susceptible to errors, which can lead to issues, delays, or even rejections.

You can streamline your submission process, maximize your chances of success, and navigate the regulatory landscape with confidence simply by learning how to avoid the most common submission mistakes.

What you’ll learn

Mastering the art of FDA forms, including how to ensure proper formatting and avoid errors in document placement

How to address technical errors with your submission

The power of utilizing a submission checklist to catch issues and ensure accuracy

Avoiding common submission mistakes is essential for a smooth and efficient regulatory review when pursuing approvals of new drugs and products.

About the authors

Rachel Bombara

Sr. Regulatory Services Manager

Rachel Bombara has more than 13 years of experience in regulatory operations and helping sponsors achieve their eCTD submission goals. She has led the eCTD submission publishing of a variety of application types for different regions, from small amendments to large-scale original marketing applications, as well as mentored and trained others in eCTD publishing and submission management. She has also spoken at industry conferences on topics pertinent to investigational and marketing related submissions and produced a variety of blogs, presentations, and other materials to share valuable industry insights.

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About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.