What is the process for starting my own business for direct EB-5 if I have no visa yet?

You will have to handle startup activities remotely, or during a visit here (even visitors can do some basic business startup work). Since the I-526 petition does not allow for concurrent adjustment of status (green card application), if you were to get to a point to actually get the business operational, a U.S. manager would be needed.

If you are from an E-2 treaty country, it may be best to apply for an E-2 first and ensure you are in a targeted area so you can invest at the lower amount. If you want to go straight for the EB-5, you will have to hire a manager because the process takes at least three years to get an approval and you can set up the business but you cannot work until the green card is approved, unless you apply for a nonimmigrant work visa first.

Many investors will travel to the U.S. using their B-1/B-2 visa in order to initiate the investment process, attend meetings, form their company, sign contracts, and employ individuals. All of these activities can be undertaken while visiting the U.S. for temporary business. I would recommend hiring an assistant manager of sorts who can help move the process forward while you are abroad as well.

You need to invest into a new commercial enterprise first in order to be eligible for the direct EB-5 visa. You do not need a visa to start a business in the U.S. Attorneys or accountants here in the U.S. can help you with company registration without you being present in the U.S.