Company: ARAI
Filing Date: 2025-07-15
Form Type: S-1/A
Source: 0001641172-25-019572
Chunk: 103

Company: Arrive AI Inc.
Filing Date: 2025-07-15
Form: S-1/A
Chunk 103
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sell or transport medical or biological products or prescriptions, there are several regulations related to the transportation of pharmaceutical
and biomedical products and our potential third party service providers may be subject to such regulations, described further below.

Title 21 of the Code of Federal Regulations (CFR)
regulates the shipping, warehousing, distribution, and record keeping of pharmaceuticals. Because of the sensitive nature of some pharmaceutical
products, there are many federal, state, and local laws that dictate how to package and transport the items. There are also several different
federal agencies with oversight, including the Food and Drug Administration (FDA), the FDA’s role is to protect the public’s
health by ensuring that the items to be consumed are safe. Prescription drugs and medical devices 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