Question 1

What is FDA registration?

Accepted Answer

FDA registration is the filing process that allows a foreign facility, brand, or product category to meet the US entry requirements that apply to it. The exact filing depends on whether you sell food, cosmetics, or drug products.

Question 2

Do I need FDA registration to export to the USA?

Accepted Answer

Many exporters do. Food facilities commonly need FDA food facility registration, cosmetics businesses may need facility registration and product listing, and drug manufacturers often need a more detailed registration and listing process. The right answer depends on what you sell.

Question 3

What is a US FDA Agent?

Accepted Answer

A US Agent is the US-based contact listed for many foreign FDA-related registrations. The FDA can use that contact point when it needs to send notices or communicate about your filing.

Question 4

How long does the registration process take?

Accepted Answer

Most standard food and cosmetics work moves within 3–5 business days after we receive complete information. Drug work is handled on a quote-first basis because the scope is more case-specific.

Question 5

What documents do I need?

Accepted Answer

Most filings start with your legal company name, facility address, contact details, product type, and any existing identifiers such as DUNS or FEI if you already have them. We tell you exactly what is needed once your service is selected.

Question 6

What payment methods do you accept?

Accepted Answer

We accept credit and debit card payments processed securely online.

Question 7

What happens after I place my order?

Accepted Answer

You complete the application or quote form, our team reviews the details, and we start the filing path that matches your service. We contact you if anything is missing and send confirmation when the work is completed or the next step is ready.

Question 8

Do you offer refunds?

Accepted Answer

Refunds depend on the stage of the work and the service purchased. If no filing work has started, a refund may be available. Once filing or document work has already begun, the refundable amount may be limited.

Question 9

Does every food company need FDA registration?

Accepted Answer

Not every business in the food chain does, but many foreign facilities that manufacture, process, pack, or store food for the US market need FDA food facility registration before shipment.

Question 10

What is a DUNS number and why do food exporters need it?

Accepted Answer

A DUNS number is a business identifier used during FDA food facility registration. If your filing requires one and you do not already have it, we can request it as part of the setup.

Question 11

What is a Shell Egg Producer Registration?

Accepted Answer

Shell Egg Producer Registration is a separate FDA-related filing that can apply to facilities producing shell eggs for the US market. It may be needed in addition to standard food facility registration.

Question 12

Does my food facility registration need to stay current?

Accepted Answer

Yes. Your FDA food facility registration must be kept active and accurate while you are shipping to the US market. Your US Agent coverage should also remain active during this period.

Question 13

What is a US Agent for food companies?

Accepted Answer

A US Agent is the US-based contact listed on the FDA registration for a foreign food facility. Foreign facilities usually need one, and we provide that service with the relevant package.

Question 14

Can I register without a DUNS number?

Accepted Answer

In many food registration cases, a DUNS number is expected. If you do not have one yet, the usual path is to obtain it first and then move forward with the FDA filing.

Question 15

How do I know my registration was successful?

Accepted Answer

After the filing is completed, we send confirmation and the registration details that show the work was submitted and accepted on the proper path. We also keep records so you can refer back to them later.

Question 16

What is MoCRA?

Accepted Answer

MoCRA is the newer US cosmetics law that added formal facility registration and product listing rules for many businesses selling cosmetic products in the American market.

Question 17

Does my cosmetic brand need to register with the FDA?

Accepted Answer

In many cases, yes. Foreign cosmetic manufacturers commonly need facility registration, and products may also need to be listed before they are sold in the United States.

Question 18

What is an FEI number?

Accepted Answer

An FEI number is a facility identifier used in FDA-related systems. If you do not already have one, we can help obtain it before the registration work moves forward.

Question 19

What is Cosmetic Product Listing?

Accepted Answer

Cosmetic Product Listing is the step where product details are entered on the required FDA path for cosmetics. If listing applies to your case, each product should be listed correctly.

Question 20

What is a Label Review and why do I need it?

Accepted Answer

A label review checks your product label for common problems before they create delays or market issues. It helps you catch avoidable mistakes in wording, claims, and presentation.

Question 21

When does my cosmetic facility registration renew?

Accepted Answer

Cosmetic registration timing depends on the current FDA requirements and the status of your facility record. We track the timing for our clients and contact them before the next filing step is due.

Question 22

What is a US Agent for cosmetic companies?

Accepted Answer

For foreign cosmetic facilities, a US-based contact is commonly part of the filing structure. We include Year 1 US Agent coverage with the main facility registration service and bundle options.

Question 23

I already have an FEI number — what do I need next?

Accepted Answer

If you already have an FEI number, the next step is usually the actual facility registration and, if required, product listing. The right path depends on how many products you sell and whether the labels also need review.

Question 24

Do foreign drug manufacturers need FDA establishment registration?

Accepted Answer

In many cases, yes. If you manufacture drug products for the US market, FDA establishment registration is often part of the required setup before products can be listed or sold properly.

Question 25

What is an FEI number for drug filings?

Accepted Answer

An FEI number is a facility identifier used in FDA-related drug systems. It is commonly needed before or during establishment registration work.

Question 26

What is an NDC Labeler Code?

Accepted Answer

The NDC Labeler Code is part of the product identification structure used for drug listings in the US market. It is usually needed before product listings can move forward correctly.

Question 27

Do I need to list every drug product?

Accepted Answer

If your products need to be listed, each drug product should be handled correctly on the FDA listing path. That is why we offer both single listing support and larger bundle options.

Question 28

Why does the Drug page use a quote flow instead of direct checkout?

Accepted Answer

Drug work is more case-specific than standard food or cosmetics filings. We review the scope first so you receive the correct pricing and the right process before payment is requested.

Question 29

Do foreign drug facilities need a US Agent?

Accepted Answer

A US Agent is commonly part of the setup for foreign drug manufacturers. We include Year 1 coverage in the main registration bundle and service option.

Question 30

How long does the quote response take?

Accepted Answer

We reply within 24 hours after reviewing the information in your quote form. If the scope is clear, we send pricing confirmation and the next step quickly.

Question 31

What happens after I request a quote?

Accepted Answer

We review your details, confirm which filings apply, send pricing, and provide the next payment step so the work can begin on the correct path.

Question 32

What is a Responsible Person for EU cosmetics?

Accepted Answer

The Responsible Person is the EU-based party connected to cosmetic compliance obligations in the European market. Foreign brands usually need that role in place before products are sold in the EU.

Question 33

What is CPNP registration?

Accepted Answer

CPNP registration is the product notification step used for cosmetics sold in the European Union. It records the required product information on the EU system before market entry.

Question 34

Do foreign cosmetic brands need an EU Responsible Person?

Accepted Answer

Yes, foreign cosmetic brands usually need an EU Responsible Person before products are placed on the EU market. That role gives the brand a valid contact point inside the European Union.

Question 35

Do I need to register every cosmetic product in CPNP?

Accepted Answer

If your products are being sold in the EU and fall under the cosmetics rules, each product should be notified correctly. The exact scope depends on how many separate products and variants you have.

Question 36

What details do you need before starting EU cosmetics work?

Accepted Answer

We usually need your company details, product names, product type, packaging and label information, and the country where the products will be marketed. If anything else is needed, we tell you before the work starts.

Question 37

How long does EU cosmetics registration take?

Accepted Answer

Standard EU cosmetics work usually moves quickly once the required product details are complete. Timing depends on how many products are included and whether the supporting information is ready at the start.

Question 38

What happens after I place an order for EU cosmetics services?

Accepted Answer

You complete the application form, we review the company and product details, and then we handle the Responsible Person or CPNP registration work tied to your order.

Question 39

Can you handle both Responsible Person assignment and product registration together?

Accepted Answer

Yes. That is why we offer an EU CPNP bundle that combines Responsible Person assignment with multiple product registrations for brands that want one clean order path.

Preguntas que los exportadores hacen antes de presentar sus trámites

Respuestas escritas para exportadores, no para abogados