We hired a consultant to help put together the paperwork and deal with the actual submission itself. They did not support us on putting our documentation together, and could not provide specific answers to questions we had.
What they did provide was a means to package our paperwork together in a way that is recognizable to FDA reviewers, and the resulting work is what you see in the StartupFDA repo.
We still had to produce all the work, and interpret the FDA guidelines on our own. It was a bit of a compromise on speed and cost, but worked for us.
What they did provide was a means to package our paperwork together in a way that is recognizable to FDA reviewers, and the resulting work is what you see in the StartupFDA repo.
We still had to produce all the work, and interpret the FDA guidelines on our own. It was a bit of a compromise on speed and cost, but worked for us.