FDA Registration Form

1

Your Production Facility (1of2)* This field is required.

Legal Company Name

Corporate Designation

Business Registration No (VAT/Tax ID/Local Tax Reg. No)

Contact Name

Job Title

Facility Phone (incl. country code)

Email

2

Your Production Facility (2of2)* This field is required.

Facility Address

City

State/Province/Region

Postal Code

Country

3

What does your facility need?* This field is required.

FDA Registration Renewal (switch U.S. Agent)

New FDA Registration

4

Who currently acts as your U.S. Agent?* This field is required.

Registrar Corp

Another professional U.S. Agent provider

U.S. importer / distributor

Individual representative

Not sure

Other

5

Production Facility U.S. FDA Information* This field is required.

FDA REGISTRATION No

FDA PIN No

DUNs Number or Company's GEMH

6

360o FDARegistry Renewal Service Options* This field is required.OPTION #1: U.S. Agent Service INCLUDES: only standard FDA Registration Renewal → Best for companies that only need their mandatory Renewal and U.S. Agent service. OPTION #2: U.S. Agent Service + Regulatory Support INCLUDES: → Renewal + year-round Regulatory Support for any FDA issue. Paid and ad-hoc services are not included. → direct WhatsApp access, regulatory guidance and 3 Prior Notice filings during the service period. Recommended for active U.S. exporters

I understand the new available options. I am ready to choose.

7

How would you like to renew?* This field is required.Choose the level of FDA support your company needs.

OPTION #1: U.S. Agent Service

OPTION #2: U.S. Agent Service + Regulatory Support

8

OPTION #1: U.S. Agent Service* This field is required.Choose your Preferred FDA Package

RENEWAL 1 year (valid for 2027): €425+VAT (apply to FDA-Registered clients)

RENEWAL 2 years (valid for 2028): €790+VAT (apply to FDA-Registered clients)

9

OPTION #2: U.S. Agent Service + Regulatory Support* This field is required.Choose your Preferred FDA Package

RENEWAL 1 year (valid for 2027): €695+VAT (apply to FDA-Registered clients)

RENEWAL 2 years (valid for 2028): €1295+VAT (apply to FDA-Registered clients)

10

Would you like us to check your U.S. product labels?Label Review is free and includes a brief compliance report. Any corrections will be quoted separately and performed upon your written approval.

Drag and drop files here

Select files to upload

Max. file size: 10.6MB

11

When do you need your FDA Registration?* This field is required.

As soon as possible

Before my first U.S. shipment

I am preparing for future U.S. exports

12

Expected shipment date* This field is required.

Date

13

Does the information provided refer to the physical location where the food is manufactured, processed, packed or stored?* This field is required.Facility Status: Tell us more about your facility

YES

NO

14

Physical Location Information* This field is required.FDA requires companies to register their physical locations where the production is taking place.

Facility Physical Address

City

State/Province/Region

Postal Code

Country

15

Is this facility a subsidiary of a parent company?* This field is required.Is more than 50% of this facility owned by another company?

YESNO

16

Provide the parent company's information.* This field is required.

Country

Legal Company Name

Corporate Designation

Street

City

State/Province/Region

Postal Code

Phone Number

17

Provide Information for the Facility's Emergency Contact Person (ECP).* This field is required.Appoint a contact person who is readily available for any FDA-related matters.

Contact Name

Job Title

Please enter your email

Please enter your phone

18

Enter any Trade Names this facility operates under.

19

This facility handles food for:* This field is required.

Human Consumption

Animal Consumption

20

What type of product(s) does your company manufactures?* This field is required.For Human Consumption

Food

Beverage

Dietary Supplements

Wine

21

Identify the product categories handled by this facility.* This field is required.For Human Consumption

22

Food for Human Consumption.* This field is required.Select All That Apply

23

Identify the product categories handled by this facility.* This field is required.For Animal Consumption

24

Food for Animal Consumption.* This field is required.Select All That Apply

25

360o FDARegistry Service Options* This field is required.OPTION #1: U.S. Agent Service INCLUDES: only standard FDA Registration → Best for companies that only need their mandatory U.S. Agent service. OPTION #2: U.S. Agent Service + Regulatory Support INCLUDES: → Renewal + year-round Regulatory Support for any FDA issue. Paid and ad-hoc services are not included. → direct WhatsApp access, regulatory guidance and 3 Prior Notice filings during the service period. Recommended for active U.S. exporters

I understand the new available options. I am ready to choose.

26

How would you like to register?* This field is required.Choose the level of FDA support your company needs.

OPTION #1: U.S. Agent Service

OPTION #2: U.S. Agent Service + Regulatory Support

27

OPTION #1: U.S. Agent Service* This field is required.NOTE: For New Registrations, an additional one-time fee of €325 + VAT applies.

Valid Though 12/2027: €750+VAT

Valid Though 12/2028: €1115 +VAT

28

OPTION #2: U.S. Agent Service + Regulatory Support* This field is required.NOTE: For New Registrations, an additional one-time fee of €325 + VAT applies.

Valid Though 12/2027: €1020+VAT

Valid Though 12/2028: €1620+VAT

29

Would you like us to check your U.S. product labels?Label Review is free and includes a brief compliance report. Any corrections will be quoted separately and performed upon your written approval.

Drag and drop files here

Select files to upload

Max. file size: 10.6MB

30

Non-Disclosure Agreement* This field is required.The Disclosing Party provides FDA Compliance Services, including registration, renewal and labeling services ("Services") to production facilities, including the Recipient. These Services may include, among others, FDA facility registration and label compliance. Confidential Information: includes any information disclosed by the Disclosing Party to the Recipient, whether orally, in writing, or electronically, that is identified as confidential or should reasonably be understood as such. Information that should not be disclosed are the identity and brand name of the Disclosing Party, details of the Services, pricing, and any proprietary information.

AGREEDISAGREE