Company: ARAI
Filing Date: 2025-05-13
Form Type: S-1/A
Source: 0001641172-25-009841
Chunk: 94

Company: Arrive AI Inc.
Filing Date: 2025-05-13
Form: S-1/A
Chunk 94
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 undergo rigorous screening and testing to
ensure they work as the manufacturer claims. Within the context of pharmaceuticals, this means information on the approved temperature
range for shipping, warehousing, and distribution. In addition to the FDA’s temperature control requirements, there are other requirements
which include hygiene, security, and recordkeeping. The packaging procedures of manufacturers and the transportation third parties must
ensure compliance with FDA’s temperature control requirements. When transporting products that require temperatures outside the
normal bounds, it usually requires a particular type of vehicle or trailer. These vans and trucks are modified to allow temperature control
while traveling. This helps ensure the products stay within the safe temperature range. The modifications to the trailers and vehicles
often include improved gaskets, seals, and partitions that allow the transport of products in different temperature zones. The FDA also
sets state licensing laws for pharmaceutical companies.

The most relevant of the FDA requirements is the
cold supply chain, which is crucial to many different industries. If products go outside of their safe temperature range, it can lead
to ineffective medications, vaccines, or devices. This is what makes compliance so crucial in the medical community. For most products,
storage and transportation are easy so long as the temperature range remains between 55- and 77-degrees Fahrenheit, but once outside
of that comfortable range, things start to become more challenging. Within the cold supply chain, there are four different steps. The
first stage is where the supply is from, such as the factory or plant. The second step is the transportation stage. This stage can occur
multiple times and is when the medical devices or medication are on the transport vehicle. The third step, storage, is whenever the product
is in a cold storage location before arriving at its final destination. This step also has the possibility of happening more than once.
The last step is arrival at the market when the products reach the buyers. This is the stage where the items remain before being sold
or administered. Our Company will not guarantee the temperature of any of these items as this is a requirement applicable to manufacturer’s
and transportation third parties in connection with their packaging procedures.

Transportation, when transporting products that
require temperatures outside the normal bounds, it usually requires a particular type of vehicle or trailer. These vans and trucks are
modified to allow temperature control while traveling. This helps ensure the products stay within the safe temperature range. The modifications
to the trailers and vehicles often include improved gaskets and seals. Some even have partitions that allow the transport of