5 Signs You’re at Risk for a Delayed Submission

When you're deep in the trenches of preparing an IND or NDA, it can be hard to know if you're on track — or heading for trouble.

For small biotech companies with limited time and resources, early warning signs are critical. If you spot these red flags, it’s time to act fast to course-correct before the FDA sees the cracks.

Delayed Submission Risk 1. You Don’t Have a Master Submission Checklist

If your team is tracking documents informally — or worse, "in everyone's heads" — you’re already at risk.

A detailed, up-to-date checklist of every required document, study, and dataset is non-negotiable for a complex submission.

Ask yourself:

Can I quickly see the real-time status of every submission piece, including who owns it and when it's due?

Delayed Submission Risk 2. Your Key Study Reports Aren’t Final Yet

If pivotal nonclinical or clinical study reports are still drafts when you’re a few months (let alone weeks!) from filing, you're cutting it close.

Draft reports are rarely submission-ready — they often require rounds of revisions, data clarifications, and formatting fixes to meet FDA standards.

Ask yourself:

How many critical reports are still "in progress," and what's the realistic timeline to get them to final?

Delayed Submission Risk 3. CMC Data Is Coming in Late — or Changing

Chemistry, Manufacturing, and Controls (CMC) is a silent submission killer.

If your stability data, validation results, or process descriptions are delayed or evolving close to the deadline, the risk of a major CMC gap is high.

Ask yourself:

Are we still locking down basic CMC details like drug substance specs or manufacturing facilities?

Delayed Submission Risk 4. Nobody Owns Risk Management

If you don’t know who’s responsible for identifying, tracking, and mitigating risks across the submission, you’re setting yourself up for surprises.

Ask yourself:

Do we have a current risk register — and a plan for our top 3 highest risks?

Delayed Submission Risk 5. You’re Counting on Last-Minute Publishing

eCTD publishing isn't just "save as PDF" and hit submit. If your publishing team (internal or vendor) is only getting involved during the last couple of weeks, you’re taking a big gamble.

Formatting, technical validation, and document fixes always take longer than expected.

Ask yourself:

Are we regularly interacting with our publisher, sending documents for submission readiness on a rolling basis, and planning for a rolling review? Have we informed our publisher of any critical path documents and ensured there’s a plan in place to get them into the submission?

Don’t Wait for a Crisis

Spotting trouble early is your best defense against submission delays.

If any of these five signs feel uncomfortably familiar, it's time to slow down, reassess, and tighten up your plans — before the FDA (or your investors) force your hand.

Need help steering your submission back on track?

We specialize in rescue missions — from gap analysis to risk management to submission publishing support. Facing a crisis? Reach out today — we can help!