Timing is Everything: Why Early FDA Engagement Can Make or Break Your Development Timeline

The right regulatory strategy can be the difference between a product that launches on time and on budget, and one that doesn't launch at all. Don't leave timing to chance.

When it comes to medical device and pharmaceutical development, one conversation with the FDA can save you months of delays and thousands of dollars—or cost you both if timed poorly. The difference often comes down to strategy and timing.

The Hidden Cost of Late Engagement

Too many companies wait until they're deep into development before reaching out to the FDA. By then, course corrections become expensive, timelines stretch, and budgets strain. The reality is that early, strategic engagement with FDA divisions like CDRH, CBER, and CDER can streamline your entire development process.

Strategic Touchpoints That Matter

Successful regulatory navigation isn't about frequent communication—it's about meaningful communication at the right moments. Whether you're preparing your first IND submission, planning a Q-Sub, or mapping out your clinical protocol review strategy, understanding when and how to engage can transform your development trajectory.

Early FDA engagement helps you:

Align your development approach with regulatory expectations
Identify potential roadblocks before they become costly delays
Optimize your clinical trial design from the start
Build relationships that facilitate smoother future interactions

Join the Conversation

Ready to master the art of FDA timing? Our regulatory experts will be sharing practical insights and real-world strategies in an upcoming MTEC educational webinar on September 17, 2025.

"Timing is Everything: Leveraging Early FDA Engagement to Streamline Development and Accelerate Trials" features our Director of Regulatory and Quality Affairs Ellie Reynolds, Senior Regulatory Manager Carmen Brown, and Clinical Project Manager II Mateja Mowlds.

What you’ll learn:

Optimal timing for engaging FDA divisions (CDRH, CBER, CDER)
Key regulatory strategy touchpoints that matter most
When to involve the agency in clinical protocol reviews
How early engagement prevents costly delays
Practical insights for IND and Q-Sub preparations

Whether you're gearing up for your first IND or Q-Sub submission or looking to optimize your existing regulatory roadmap, this session will provide actionable insights to help your overall budget and timeline.

We are proud to partner with MTEC in bringing valuable educational content to the medtech community!

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Register for the webinar here

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About the Author:

Ellie Reynolds, MBE

Director of Regulatory Affairs and Quality Assurance

At Proxima, Ellie has been critical in contributing to and authoring regulatory strategies and assessments, pre-submission, pre-IND, IND, and IDE packets, and 510(k), De Novo, and PMA submissions for products across a range of indications, including cardiovascular, gastrointestinal, urology, surgical, diagnostic, and pediatric-specific devices. She has also been instrumental in QMS development and integration projects for both large and small companies.

Learn More

About the Author:

Carmen Brown

Sr. Regulatory Affairs Manager

Prior to joining the Proxima team, Carmen served as the QC Stability Coordinator for a biopharmaceutical company where she designed and managed a robust stability program.