Do you manufacture, prepare, propagate, compound or process drugs that are offered for import into the U.S.? You need to register your establishment with the FDA, list your products and name an U.S.-Agent.The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
To register drugs, add to shopping cart:
ANNUAL CERTIFICATION AND RENEWAL ESTABLISHMENT REGISTRATION
€550.00
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.
Obligation to renew the registration during the open period October to December. The product of an establishment not renewed by December 31 will be deemed as misbranded and subject to regulatory action. For the listing, it will be needed to submit a no change certification every year during the renewal period. As per the 2016 new rule, any product listing that is not certified as required may be considered inactive and will be removed from the NDC directory and other publications of listing data.
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Quick View €550.00
DRUGS CONSULTATION CALL
€75.00
TABS will assist you to understand and comply with Drugs products compliance requirements for your facility and products.
We will schedule a 30 mins. call to identify your needs.
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Quick View €75.00
INITIAL DRUG ESTABLISHMENT REGISTRATION, LISTING & U.S.-AGENT
€1,100.00
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.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must, at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S.-agent and importers at the time of registration.
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Quick View €1,100.00
UPDATE OF DRUG LISTINGS
€140.00
If during the year there are any changes in the existing drug listing, the drug listing should be updated immediately.
Any update outside the 3-month period will require submission for each NDC to certify the product.
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Quick View €140.00
To add to shopping cart:
The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
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Quick View €75.00
LABEL REVIEW FOR FOOD, BEVERAGE & DIETARY SUPPLEMENTS
€500.00
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.
All Foods sold in the United States need to be properly labeled. It is recommended that manufacturers and importers become fully informed about the applicable laws and regulations regarding the label of food and dietary supplements before offering them for distribution in the United States.
TABS will give you a basic review and assessment of your label. Further assistance will be quoted case by case.
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Quick View €500.00
To add to shopping cart:
The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
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Quick View €75.00
INGREDIENT REVIEW FOR FOOD, BEVERAGE & DIETARY SUPPLEMENTS
€300.00
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.
TABS specialists will help you to assess the compliance of the ingredients, additives, and color additives of your product. Schedule a consultation with us.
TABS will give you a BASIC review and assessment of your label. Further assistance will be quoted case by case.
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Quick View €300.00
To add to shopping cart: If you’re a producer select FS Compliance Consultation Call and if you’re an importer select FSVP Compliance Consultation Call.
FS COMPLIANCE CONSULTATION CALL – HUMAN FOOD
€75.00
The FDA Food Safety Modernization Act of 2011 mandates the creation of a food safety system.
The FSMA rules include those that require preventive controls for food facilities that manufacture/process, pack and hold human and animal foods and establish science-based standards for produce grown on farms.
These rules apply to domestic food producers and those in other countries who export to the United States.
TABS will assist you to understand and comply with Food Safety compliance requirements for your facility. We will schedule a 30 mins. call to identify your needs.
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Quick View €75.00
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Quick View €75.00
If YES, to add to shopping cart:
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
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Quick View €450.00
If YES, you need to register in FFR and FCE and also list your products (SIDs) with the LACF. To add to shopping cart:
The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
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Quick View €75.00
FCE REGISTRATION
€650.00
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.
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). They also need to file the processes 21 CFR 108.25(c)(2) (for processors of AF) or 21 CFR 108.35(c)(2) (for processors of LACF).
TABS will register your FCE. This is a one-time fee.
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Quick View €650.00
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
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Quick View €450.00
To add to shopping cart:
Your domestic facility must register with FDA.
The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
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Quick View €75.00
U.S. FOOD FACILITY REGISTRATION 2024
€90.00
Food Facility Registration for U.S. companies that are engaged in producing, packing, or holding food.
A domestic facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, must register with FDA, whether or not the food from the facility
enters interstate commerce (21 CFR 1.225(b)).
This is a bi-annual fee.
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Quick View €90.00
To add to shopping cart:
Based on your answer you will need the following services. The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
The FSVP plan development for importers starts at $ 800 and in order to determine the extent of the plan development a 30-minute consultation call should be added to the order. If you order the FSVP plan development based on that call, the amount of $ 80 will be deducted.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
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Quick View €75.00
FSVP PLAN DEVELOPMENT FOR IMPORTERS
€750.00
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.
The FSVP rule requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies.
TABS specialists can assist importers of food & beverage to meet the FSVP requirements. Pricing starts at $ 800, contact us for a quote.
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Quick View €750.00
U.S. FOOD FACILITY REGISTRATION 2024
€90.00
Food Facility Registration for U.S. companies that are engaged in producing, packing, or holding food.
A domestic facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, must register with FDA, whether or not the food from the facility
enters interstate commerce (21 CFR 1.225(b)).
This is a bi-annual fee.
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Quick View €90.00
To add to shopping cart:
Your foreign facility must register with FDA.
The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
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Quick View €75.00
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
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Quick View €450.00
Based on your answers you need the following service(s). The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
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Quick View €450.00
There’s no need to register your facility, but you need to be sure that your foreign supplier is registered. If you want, you can order your supplier’s food facility registration here. The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
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Quick View €450.00
To add to shopping cart:
PRIOR NOTICE
€25.00
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.
The Food Act requires that FDA receives the prior notification of food, including animal feed that is imported or offered for import into the United States. It has to be filed in the FIS system 2 days prior to the arrival of your samples to the US. We can assist you with the filing. (21 CFR 1.276 to 1.285). TABS will assist you with your 1st Prior Notice and will guide you through the process so you can file your next prior notices.
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Quick View €25.00
To add to shopping cart:
Based in your answers, you need to register your facility and then submit the Prior Notice. The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
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Quick View €450.00
PRIOR NOTICE
€25.00
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.
The Food Act requires that FDA receives the prior notification of food, including animal feed that is imported or offered for import into the United States. It has to be filed in the FIS system 2 days prior to the arrival of your samples to the US. We can assist you with the filing. (21 CFR 1.276 to 1.285). TABS will assist you with your 1st Prior Notice and will guide you through the process so you can file your next prior notices.
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Quick View €25.00
If YES, to add to shopping cart:
The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
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Quick View €450.00
Based on your answers you need the following service(s). The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
-
Quick View €450.00
There’s no need to register your facility, but you need to be sure that your foreign supplier is registered. If you want, you can order your supplier’s food facility registration here. The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
-
Quick View €450.00
To add to shopping cart:
PRIOR NOTICE
€25.00
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.
The Food Act requires that FDA receives the prior notification of food, including animal feed that is imported or offered for import into the United States. It has to be filed in the FIS system 2 days prior to the arrival of your samples to the US. We can assist you with the filing. (21 CFR 1.276 to 1.285). TABS will assist you with your 1st Prior Notice and will guide you through the process so you can file your next prior notices.
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Quick View €25.00
To add to shopping cart:
Based in your answers you need to register your facility, obtain a COLA waiver from the TTB and then submit the Prior Notice. We can help you with all the requirements. The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
COLA WAIVER
€150.00
TABS will assist you with the compliance to send your wine samples for soliciting orders or trade shows.
The TTB requires the label of alcoholic beverages to be approved before entering the market or COLA. For tasting samples, they allow requesting a waiver.
TABS will help you to get your COLA waiver fast and easily. Pricing starts at $150 per submittal, contact us for an estimate for the logistics and shipping of your samples.
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Quick View €150.00
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
FDA FOOD FACILITY REGISTRATION AND AGENT SERVICES 2024
€450.00
Food Facility Registration and Agent Service for foreign companies that are engaged in producing, packing, or holding food for human consumption.
As a foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human consumption in the United States, you must register with the FDA and must name a local US agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
-
Quick View €450.00
PRIOR NOTICE
€25.00
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.
The Food Act requires that FDA receives the prior notification of food, including animal feed that is imported or offered for import into the United States. It has to be filed in the FIS system 2 days prior to the arrival of your samples to the US. We can assist you with the filing. (21 CFR 1.276 to 1.285). TABS will assist you with your 1st Prior Notice and will guide you through the process so you can file your next prior notices.
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Quick View €25.00
To add to shopping cart:
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
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Quick View €75.00
LABEL REVIEW ANIMAL FOOD
€300.00
Animal food label and 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.
Foods sold in the United States need to be properly labeled. It is recommended that manufacturers and importers become fully informed about the applicable laws and regulations regarding the label of animal food before offering them for distribution in the United States.
TABS will give you a basic review and assessment of your label. Further assistance will be quoted case by case.
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Quick View €300.00
To add to shopping cart:
FS COMPLIANCE CONSULTATION CALL – ANIMAL FOOD
€75.00
The FDA Food Safety Modernization Act of 2011 mandates the creation of a food safety system.
The FSMA rules include those that require preventive controls for food facilities that manufacture/process, pack and hold human and animal foods and establish science-based standards for produce grown on farms.
These rules apply to domestic food producers and those in other countries who export to the United States.
TABS will assist you to understand and comply with Food Safety compliance requirements for your facility. We will schedule a 30 mins. call to identify your needs.
-
Quick View €75.00
FSVP COMPLIANCE FOR IMPORTERS CONSULTATION CALL – ANIMAL FOOD
€75.00
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.
The FSVP rule requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies.
TABS specialists can assist importers of food & beverage to meet the FSVP requirements. Pricing starts at $ 800, contact us for a quote.
-
Quick View €75.00
Based on your answers you need the following service(s). The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
FACILITY REGISTRATION ANIMAL FOOD
€450.00
Food Facility Registration and U.S.-Agent service for foreign companies that are engaged in producing, packing, or holding animal food.
A foreign facility that is engaged in manufacturing/processing, packing, or holding of food for animal consumption in the United States, you must register with the FDA and you must name a local U.S.-agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
-
Quick View €450.00
If YES, to add to shopping cart:
Based on your answers you will need the following services. The FSVP plan development for importers starts at $ 800 and in order to determine the extent of the plan development a 30-minute consultation call should be added to the order. If you order the FSVP plan development based on that call, the amount of $ 80 will be deducted.)
FSVP CONSULTATION CALL
€75.00
TABS will assist you to understand and comply with FSVP compliance requirements as an importer.
We will schedule a 30 mins. call to identify your needs.
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Quick View €75.00
FSVP PLAN DEVELOPMENT FOR IMPORTERS
€750.00
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.
The FSVP rule requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain and follow an FSVP for each food imported unless an exemption applies.
TABS specialists can assist importers of food & beverage to meet the FSVP requirements. Pricing starts at $ 800, contact us for a quote.
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Quick View €750.00
U.S. FOOD FACILITY REGISTRATION 2024
€90.00
Food Facility Registration for U.S. companies that are engaged in producing, packing, or holding food.
A domestic facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, must register with FDA, whether or not the food from the facility
enters interstate commerce (21 CFR 1.225(b)).
This is a bi-annual fee.
-
Quick View €90.00
Based on your answers you need the following service(s). The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
FACILITY REGISTRATION ANIMAL FOOD
€450.00
Food Facility Registration and U.S.-Agent service for foreign companies that are engaged in producing, packing, or holding animal food.
A foreign facility that is engaged in manufacturing/processing, packing, or holding of food for animal consumption in the United States, you must register with the FDA and you must name a local U.S.-agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
-
Quick View €450.00
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
There’s no need to register your facility, but you need to be sure that your foreign supplier is registered. If you want, you can order your supplier’s food facility registration here. The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
FACILITY REGISTRATION ANIMAL FOOD
€450.00
Food Facility Registration and U.S.-Agent service for foreign companies that are engaged in producing, packing, or holding animal food.
A foreign facility that is engaged in manufacturing/processing, packing, or holding of food for animal consumption in the United States, you must register with the FDA and you must name a local U.S.-agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
-
Quick View €450.00
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
-
Quick View €75.00
To add to shopping cart:
PRIOR NOTICE
€25.00
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.
The Food Act requires that FDA receives the prior notification of food, including animal feed that is imported or offered for import into the United States. It has to be filed in the FIS system 2 days prior to the arrival of your samples to the US. We can assist you with the filing. (21 CFR 1.276 to 1.285). TABS will assist you with your 1st Prior Notice and will guide you through the process so you can file your next prior notices.
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Quick View €25.00
Based in your answer, you need to register your facility and then submit the Prior Notice. The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
To add to shopping cart:
CONSULTATION CALL – FOOD
€75.00
TABS specialists will help you to assess the compliance requirements of your product.
Schedule a consultation with us to learn the requirements for your FDA registration. We will provide you with the materials and guidance needed to start introducing your products in the US.
This is a conference call of ½ hour and includes an email follow-up with the appropriate guidance adapted to your product/needs.
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Quick View €75.00
FACILITY REGISTRATION ANIMAL FOOD
€450.00
Food Facility Registration and U.S.-Agent service for foreign companies that are engaged in producing, packing, or holding animal food.
A foreign facility that is engaged in manufacturing/processing, packing, or holding of food for animal consumption in the United States, you must register with the FDA and you must name a local U.S.-agent for communications purposes. If you are the owner, operator, or agent in charge of a facility, you can authorize TABS specialists to register your facility on your behalf.
This is a bi-annual fee.
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Quick View €450.00
PRIOR NOTICE
€25.00
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.
The Food Act requires that FDA receives the prior notification of food, including animal feed that is imported or offered for import into the United States. It has to be filed in the FIS system 2 days prior to the arrival of your samples to the US. We can assist you with the filing. (21 CFR 1.276 to 1.285). TABS will assist you with your 1st Prior Notice and will guide you through the process so you can file your next prior notices.
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Quick View €25.00
To add to shopping cart:
COSMETIC CONSULTATION CALL
€75.00
Cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act and the Fair Packaging and Labeling (FP&L) Act.
Label review is important: Depending on the claims made, some cosmetic products may also be drugs. If a cosmetic product is also a drug, it must comply with the requirements for both cosmetics and drugs.
TABS will assist you to understand and comply. We will schedule a 30 mins. call to identify your needs.
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Quick View €75.00
To add to shopping cart:
You need to review your label claims and you may register your facility and list your ingredients.The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
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Quick View €0.00
COSMETIC LABEL REVIEW
€300.00
Label review is important, for instance, depending on the claims made, some cosmetic products may also be drugs. TABS will help you to comply.
Cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act and the Fair Packaging and Labeling (FP&L) Act.
TABS will give you a basic review and assessment of your label. Further assistance will be quoted case by case.
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Quick View €300.00
COSMETIC CONSULTATION CALL
€75.00
Cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act and the Fair Packaging and Labeling (FP&L) Act.
Label review is important: Depending on the claims made, some cosmetic products may also be drugs. If a cosmetic product is also a drug, it must comply with the requirements for both cosmetics and drugs.
TABS will assist you to understand and comply. We will schedule a 30 mins. call to identify your needs.
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Quick View €75.00
Do you manufacture, prepare, propagate, compound or process drugs that are offered for import into the U.S.? You need to register your establishment with the FDA, list your products and name an U.S.-Agent.The consultation call is optional, if you have questions or doubts, you can book a 30-minute call with us in which we will determine which services you need.
To register drugs, add to shopping cart:
ANNUAL CERTIFICATION AND RENEWAL ESTABLISHMENT REGISTRATION
€550.00
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.
Obligation to renew the registration during the open period October to December. The product of an establishment not renewed by December 31 will be deemed as misbranded and subject to regulatory action. For the listing, it will be needed to submit a no change certification every year during the renewal period. As per the 2016 new rule, any product listing that is not certified as required may be considered inactive and will be removed from the NDC directory and other publications of listing data.
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Quick View €550.00
DRUGS CONSULTATION CALL
€75.00
TABS will assist you to understand and comply with Drugs products compliance requirements for your facility and products.
We will schedule a 30 mins. call to identify your needs.
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Quick View €75.00
INITIAL DRUG ESTABLISHMENT REGISTRATION, LISTING & U.S.-AGENT
€1,100.00
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.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must, at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S.-agent and importers at the time of registration.
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Quick View €1,100.00
UPDATE OF DRUG LISTINGS
€140.00
If during the year there are any changes in the existing drug listing, the drug listing should be updated immediately.
Any update outside the 3-month period will require submission for each NDC to certify the product.
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Quick View €140.00
To add to shopping cart:
MEDICAL DEVICES ASSESSMENT
€140.00
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.
The FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. 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.
TABS will give you an initial assessment of your classification. Further assistance will be quoted case by case.
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Quick View €140.00
To add to shopping cart:
MEDICAL DEVICES ASSESSMENT
€140.00
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.
The FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. 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.
TABS will give you an initial assessment of your classification. Further assistance will be quoted case by case.
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Quick View €140.00
To add to shopping cart:
Based on your answers, you need the following services:
MEDICAL DEVICES ESTABLISHMENT REGISTRATION, DEVICE LISTING AND U.S. – AGENT SERVICE – FY2024
€700.00
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).
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a U.S. agent for that establishment.
*FY fee
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Quick View €700.00
To add to shopping cart:
MEDICAL DEVICES ESTABLISHMENT REGISTRATION, DEVICE LISTING AND U.S. – AGENT SERVICE – FY2024
€700.00
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).
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a U.S. agent for that establishment.
*FY fee
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Quick View €700.00
MEDICAL DEVICES LABEL REVIEW
€300.00
The FDA has labeling requirements for medical devices to be marketed in the U.S.
TABS will give you a basic review and assessment of your label. Further assistance will be quoted case by case.
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Quick View €300.00
If you are a European manufacturer of cosmetics looking to enter the U.S. market, FDA compliance of your cosmetics is needed. There are certain requirements that cosmetics manufactured in foreign countries must meet according to the FDA before they are permitted to be marketed to American consumers. By all means, expanding your business abroad requires a lot of organization and adjustments to regulations. 
