Two weeks · Fixed fee
Pathway review
We read what you have and tell you what the agency is likely to say — written, with the reasoning shown.
Next step
Tell us where the programme is and what date you are working back from. If we are not the right firm, we will say so and point you somewhere better.
Three ways in
Two weeks · Fixed fee
We read what you have and tell you what the agency is likely to say — written, with the reasoning shown.
Before first dose
Your nonclinical package, CMC, protocol and safety process measured against reviewer expectations.
Programme-level
An independent read on your CDMO, CRO, laboratory or quality system before others form their view.
Get in touch
Email reaches the whole senior team and is usually the fastest route. Everything is covered by a mutual NDA before you send anything you would rather we did not repeat.
[email protected]A first call is normally thirty minutes and costs nothing. We will ask what stage you are at, what date you are working back from, and what has already been decided.