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Most regulatory consultants give hyperfocused advice specific to your application, and cost in the ~$10k order of magnitude, sometimes pushing the ~$100k. Given the capital investments in applications, you'd be hard pressed to find successful, complete applications with enough details relevant to your proposal that you could simply plagiarize them.

For reference, our SBIR submission was over 200 pages, much of it containing _incredibly_ specific technical documentation about our system, clinical protocols, statistical analysis plans, etc.

Point being, it's not as simple as copy pasting a known good application.



But is this the one that got approved?

So 200 pages of technical details seems like a pretty good thing to go over, understand and then base a new application on.

The regulations have a laundry list of things that need to be included in the application, right? Looking at bad and good applications helps form a mental model of how one has to actually present the answers to those items on the list.

Of course it's not literal copypaste but which part is black magic from a system integrator point of view?

Of course hiring someone who wrote a few successful ones helps, but they are also basing their new work on their previous one, no? (Again not letter by letter obviously. And in some cases some sections require more depth, more detailed answers, in some cases they are not applicable, but good applications are similar to each other, because they are complete, they cover all the required risk assessments, etc... if not, what going on, could someone help me understand this?)


And it shouldn't be. Without the relevant knowledge to make the application you shouldn't be receiving the 'go'.




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