Why Many Biopharma CTA/IND Delays Are Avoidable
If you’re approaching a CTA or IND, the biggest risk isn’t what you know — it’s what you’ve missed.
In our experience, delays rarely come from obvious failures. They come from hidden gaps that only surface under regulatory scrutiny.
The most common ones:
- Nonclinical / toxicology strategy that does not fully support the submission
- CMC development that is not aligned with regulatory expectations
- Submission packages that lack clarity, structure, or justification
- Underestimating the level of scrutiny from regulators (EMA, FDA, MHRA)
Everything can look “on track” internally — until the questions come.
And when they do, the impact can be significant:
- 6–12+ month delays with associated burn rate increase
- Increased Expenditure to remedy situation
- Pressure from investors
- Loss of momentum at a critical milestone
The reality is simple:
Most of these issues can be identified — and fixed — before submission.
That’s where Experienced, External Review Makes the Difference.
If you’re approaching a CTA or IND and want an objective view of potential risks, feel free to reach out to us for a free consultation.