FDA Compliance Services
Browse registrations, renewals, label reviews, and expert consultations designed for international exporters seeking fast, compliant U.S. market entry.
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Food (Human)
FDA FFR Registration (U.S. Facility)
Food Facility Registration for U.S. companies that are engaged in producing, packing, or holding food.
Food (Human)
Prior Notice
The Prior Notice has to be filed 2 days prior to the arrival of your samples to the US. We can assist you with the filing.
Food (Animal)
FSVP (Foreign Supplier Verification Program)
FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies. TABS can help you to comply.
Food (Human)
Ingredients Review for Foods, Drinks and Dietary Supplements
Food ingredients including color additives are regulated by the FDA. If your product does not meet the requirements your product could be deemed adulterated or misleading.
Food (Human)
FCE Registration (LACF)
If your process acidified or low acid foods in your facility, you need to register your facility as FCE and file your processes in the LACF system.
Cosmetics
Cosmetic Label Review
Label review is important, for instance, depending on the claims made, some cosmetic products may also be drugs. TABS will help you to comply.
Drugs
Annual Certification and Renewal Establishment Registration
The establishment registration needs to be renewed every year and needs to submit a “no change” certification if there is no change in drug listing.
Food (Animal)
FDA FFR Registration (U.S. Facility)
Food Facility Registration for U.S. companies that are engaged in producing, packing, or holding food.
Food (Human)
Renewal FDA FFR
Food Facility Registration and Agent Service Renewal 2025-26 for foreign companies that are engaged in producing, packing, or holding food for human consumption.
Food (Animal)
FDA FFR Agent and Registration
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human or animal consumption.
Medical Devices
Medical Devices Establishment Registration, Listing & U.S. Agent
Establishments engaged in the manufacturing or other activities of medical devices to be marketed in the US need to register the facility, list the devices and name an agent for communication purposes.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. (Title 21 CFR Part 807).
Food (Human)
Small Business Nutrition Labeling Exemption
Nutrition Labeling Exemption for Small Businesses.
Consultation
Medical Consultation Call
Schedule a consultation with us to learn the requirements for your FDA compliance.
Food (Human)
FSVP Importer
FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies. TABS can help you to comply.
Additional Services
FURLS Account Creation and Link FDA Registration
Create a FURLS account (FDA Unified Registration and Listing System) in the FIS (FDA Industry System) and link to your FDA facility's registration.
Cosmetics
Cosmetic Registration and Filing Cosmetic Product Ingredient Statements (MoCRA)
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.
Drugs
Initial Drug Establishment Registration, Listing & U.S. Agent
Manufacturers of drugs to be imported in the U.S. need to register with the FDA and list the drugs. TABS can assist you to comply.
Food (Animal)
QFA - Qualified Facility Attestation Submission
This service is included in the FDA FFR Registration service.
Additional Services
FDA FFR - Registration Certificate
TABS can issue a company certificate of FDA registration to confirm that the facility has been successfully registered at the FDA Food Facility Registration for the current period.
Food (Animal)
Prior Notice
The Prior Notice has to be filed 2 days prior to the arrival of your samples to the US. We can assist you with the filing.
Food (Human)
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SID Registration
Commercial processors who manufacture, process, or pack acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as “low-acid canned foods” or “LACF”) must register their facility as FCE (Food Canning Establishment) 21 CFR 108.25(c)(1) (for AF) or 21 CFR 108.35(c)(1) (for LACF).
Medical Devices
Medical Devices Assessment
TABS can assist you in determining if a product is regulated by the FDA as a medical device and to confirm the regulatory class that applies to your device.
Medical Devices
Medical Devices Label Review
The FDA has labeling requirements for medical devices to be marketed in the U.S.
Food (Animal)
Renewal FDA FFR (U.S. Facility)
Food Facility Registration for U.S. companies that are engaged in producing, packing, or holding food.
Food (Human)
Label Review for Foods, Drinks and Dietary Supplements
Label compliance is an important aspect of doing business in the U.S. If your product does not meet the requirements your product could be deemed mislabeled or misleading.
Food (Animal)
SID Registration
Commercial processors who manufacture, process, or pack acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as “low-acid canned foods” or “LACF”) must register their facility as FCE (Food Canning Establishment) 21 CFR 108.25(c)(1) (for AF) or 21 CFR 108.35(c)(1) (for LACF).
Food (Human)
QFA - Qualified Facility Attestation Submission
This service is included in the FDA FFR Registration service.
Consultation
FSVP Consultation Call
TABS will assist you to understand and comply with FSVP compliance requirements as an importer.
Alcohol & Beverages
COLA Waiver
TABS will assist you with the compliance to send your wine samples for soliciting orders or trade shows.
Food (Animal)
Small Business Nutrition Labeling Exemption
Nutrition Labeling Exemption for Small Businesses.
Food (Human)
Renewal FDA FFR (U.S. Facility)
Food Facility Registration for U.S. companies that are engaged in producing, packing, or holding food.
Food (Animal)
FCE Registration (LACF)
If your process acidified or low acid foods in your facility, you need to register your facility as FCE and file your processes in the LACF system.
Food (Animal)
Label Review for Foods, Drinks and Dietary Supplements
Animal food label and ingredients including color additives are regulated by the FDA.
Drugs
Update of Drug Listing
If during the year there are any changes in the existing drug listing, the drug listing should be updated immediately.
Additional Services
DUNS Assistance
This is an FDA requirement beginning October 1st, 2020. TABS will apply for your DUNS number on your behalf.
Food (Animal)
Renewal FDA FFR
Food Facility Registration and Agent Service Renewal for foreign companies that are engaged in producing, packing, or holding food for human or animal consumption.
Consultation
Cosmetic Consultation Call
Schedule a consultation with us to learn the requirements for your FDA compliance.
Consultation
Food Safety Compliance Consultation Call
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
Food (Human)
FDA FFR Agent and Registration
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
Consultation
Drug Consultation Call
Schedule a consultation with us to learn the requirements for your FDA compliance.
Food (Animal)
Ingredients Review for Foods, Drinks and Dietary Supplements
Human food ingredients including color additives are regulated by the FDA. If your product does not meet the requirements your product could be deemed adulterated or misleading.
Not sure which service you need?
Our FDA compliance experts can help you determine the right services for your products and market entry strategy.
