Services
Professional services offered
To sell in the US
FDA Registration
Bravo Compliance assists you in registering your firm with the FDA.
To import food products into the US, it is mandatory to register your firm as a foreign producer/exporter with the FDA. Once completed the online registration procedure, your firm will be provided with an FDA registration number, which shall be reported on all the export documents for your merchandise shipped to America.
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U.S. Agent
You can engage Bravo Compliance as your US Agent for the FDA registration process.
To register your firm with the FDA, you need to officially designate a US-resident natural or legal person, to act in the role of US Agent for your firm. The US Agent is a third-party consultant retained by your firm as a communication contact with the FDA for the FDA registration procedure.
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$380 per year (additional facility) $350
US Applicable Laws and Regulation
Bravo Compliance pins down the US laws and regulations relevant to your firm and your food products.
Before exposing your product at tradeshows or selling your products in the US, including the sales through web portals like Amazon, it is crucial to previously identify the specific US laws and regulations attaining to your products, to avoid running into any incompliance notifications by the FDA.
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Starting from $100 (additional product category) $85
FSMA Compliance
Bravo Compliance evaluates your status of compliance with the FSMA requirements and sketches the steps to reach full compliance.
To sell your products on the US local markets, or even expose samples at American trade fairs, as well as trade your merchandise through web portals like Amazon, your firm needs to previously determine its status of compliance with the specific US laws and regulations attaining to your production processes, single ingredients, and single categories of finished products bound to enter the American market.
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Starting from $250 (additional product category) $200
FSVP Agent
For all concerning procedures implied in the importation of your products into the US, Bravo Compliance can act on behalf of your firm in the capacity of FSVP Agent.
To sell your products on the US local markets, or even expose commercial samples at American trade fairs or trade your merchandise through web portals like Amazon, your firm must officially designate a US resident, either a natural or legal person, professionally qualified to act in the role of FSVP Agent, who will be responsible for the compliance of the product with the relevant US import rules before the FDA, during the carrying out of all the import procedures.
* We can act as your FSVP Agent only if you will have from us our service of Qualified Individual PCQI to develop for you a FSVP Manual for each product that you import into the United States.
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Starting from $275 (additional Entry) $250
*Our offer will be confirmed once viewed the producer’s documentation relevant to the food safety rules compliance
Label Editing and Upgrading
Bravo Compliance reviews and upgrade your labels to comply with the relevant US laws and regulations.
To sell your products on the US local markets, or even expose commercial samples at American trade fairs or trade your merchandise through web portals like Amazon, you need to previously ascertain that the labeling standards of your products meet the requirements of the relevant US regulations and the description of nutritional data, allergens, and additives, along with all other features of your labels, comply with such rules.
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From $850 (additional Label) $780
Qualified FSVP Contact for FDA Communication
Bravo Compliance can act in behalf of your firm in the US as a qualified FSVP contact before the FDA for all the compliance and clearance procedures required for any products that you are importing into the United States.
The US importers, as well as the foreign producers that import food products into America by means of their own US subsidiary companies, which do not have employees nor representatives professionally qualified in the matter of FSVP rules, must retain an official FSVP Agent. The latter is an independent qualified professional residing in the US, either a natural or legal person, who play the role of a non-financial/commercial representative of your firm before the FDA, for the communications and exchange of information with the agency in relation to the import into the US of your human food products. Moreover, the Agent monitors and verifies the ongoing updating of the FSVP Manual activities, as required by the relevant FDA dispositions.
* We can act as your FSVP Agent only if you will have from us our service of Qualified Individual PCQI to develop for you a FSVP Manual for each product that you import into the United States.
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1. Ensuring importer identification at entry. The work done by our qualified FSVP Agent;
2. Evaluating during each entry the foreign supplier’s FDA Dashboard Data in relation to Import Alerts, Warning Letters, Recalls and Import Refusals. The work done by our qualified FSVP Agent;
3. Developing, updating and following the FSVP Standard Operating Procedures (FSVP Manual/SOP). The work done by our qualified FSVP Agent;
4. Keeping the ongoing FSVP Manual, FSVP activities and all the FSVP documents updated and maintain records of them for at least 2 years for an FDA representative as required by FSVP regulation. The work done by our qualified FSVP Agent;
5. Guarantee to the U.S. clients the compliance with the FSVP regulation. Keeping the mentioned activity updated and valid on a yearly basis. The work done by our qualified FSVP Agent;
6. Managing and updating the FSVP compliance on your U.S. client’s portal. Keeping the mentioned activity updated and valid on a yearly basis. The work done by our qualified FSVP Agent;
7. Guarantee to the FDA the compliance with the FSVP regulation. The work done by our qualified FSVP Agent;
8. Assisting you in the context of the FDA audits relevant to your firm’s compliance with the Foreign Supplier Verification Program (FSVP) regulation. – The work done by our qualified FSVP Agent and our PCQI qualified individuals;
9. Monitoring any new implementation and/or changes made by FDA and/or USDA to your U.S. food requirements to keep your firm updated on it and in compliance with the US food regulation. The work done by our qualified FSVP Agent.
From $480/monthly (additional supplier and/or product category) $350/monthly
*Our offer will be confirmed once viewed the producer’s documentation relevant to the food safety rules compliance.
Qualified Individual PCQI
Bravo Compliance can act as your FSVP Qualified Individual (PCQI).
The FSVP importer that does not dispose of personnel professionally familiar with the regulatory requirements to carry out the import operations, must formally retain an US resident professional competent in this specific matter to act as a FSVP Qualified Individual for Prevention Controls (PCQI) and draft part of the FSVP Manual for the importer, as required by the relevant FDA rules.
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Bravo Compliance will carry out for your firm the following activities:
1. Conducting hazard analysis for each imported food as required under Foreign Supplier Verification Program regulation, 21 CFR part 1, subpart L;
2. Evaluating and approve each food imported and the foreign supplier as required under Foreign Supplier Verification Program regulation, 21 CFR part 1, subpart L;
3. Determining and performing supplier verification activities as required under Foreign Supplier Verification Program regulation, 21 CFR part 1, subpart L.
From $3.850*/yearly (additional product category from the same supplier) $2.850/yearly
*Our offer will be confirmed once viewed the producer’s documentation relevant to the food safety rules compliance.
Qualified Individual (PCQI) for USDA Strengthening Organic Enforcement Regulation
Bravo Compliance can act as your Qualified Individual (PCQI) for USDA Strengthening Organic Enforcement Regulation.
The importer that does not dispose of personnel professionally familiar with the USDA Strengthening Organic Enforcement regulatory requirements to carry out the import operations, must formally retain a US resident professional competent in this specific matter to act as a Qualified Individual and draft the Organic System Plan for the importer, as required by the USDA rules
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Bravo Compliance will develop and carry out for your firm the following activities:
- Organic System Plan including SOP (Standard Operating Procedure) in place for the record keeping, traceability (including audit trail and in-out balance), staff-training, Self-control and continuous Implementation procedures;
- Qualification of Suppliers including if applicable the third party warehouse(s) and the transportation company (ies);
- Fraud Prevention Plan (SOP in place for Fraud Monitoring and Prevention);
- Analysis of hazards related to the importation of Organic Products;
- MOCK Recall Procedure;
- Assist your firm to become Organic Certified by a Certifier Company as required by the USDA Strengthening Organic Enforcement Regulation;
- Assist your firm to maintain the Organic Certificate as required by USDA Strengthening Organic Enforcement Regulation.
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Upgrade Your FSMA Compliance Status
Bravo Compliance can assist you in upgrading your firm’s compliance with the FSMA regulations and getting ready to export your food products into America.
Before shipping to and selling your merchandise on the American market, it is crucial to provide documental proof of preventive controls implemented, and the risk analysis principles on which they are founded. at all the stages of the production processes subjected to the HARPC regulation (in force in the US) and NOT the HACCP regulation (in force in the EU).
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HARPC Plan (Food Safety Plan)
$850* (additional product category) $750
*Our offer will be confirmed once viewed the producer’s documentation relevant to the food safety rules compliance.
FDA Audit on FSVP Compliance
In the course of the compliance procedure, your firm, as a foreign supplier that imports human food products into the US, is subject to an FDA audit aimed to verify your status of compliance with respect to the regulation Foreign Supplier Verification Program (FSMA).
Bravo Compliance can provide your firm with all the information and e-tools needed to manage the administrative formalities required in your case, in all the stages of your import process. At this stage, Bravo Compliance is your representative in the context of the FDA audit on FSMA regulation compliance
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Hourly Rate for a remote Regulatory Audit (Assistance with FDA Audit in remote mode)
$1.650* (additional product category) $1.500
* Final price may vary depending on the firm’s location and possible living costs to be added. *These fees do not include any out-of-pocket cost incurred by the service provider in connection with the performance of the Services and will be billed separately, but only to the extent that BRAVO has obtained the client’s prior written approval of such costs before incurring such costs.
FDA Audit on PCHF Compliance
Bravo Compliance can assist you in the context of the FDA audits relevant to your firm’s compliance with the FSMA regulation Preventive Controls for Human Food.
The producers who market their products in the US are supposed to pass an FDA audit at their facilities to ascertain the correct implementation of the (FSMA) PCHF rules.
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Daily Flat Rate (8h) for an on-site Regulatory Audit (Assistance with FDA Audit)
$1.650* (additional product category) $1.500
* Final price may vary depending on the firm’s location and possible living costs to be added. *These fees do not include any out-of-pocket cost incurred by the service provider in connection with the performance of the Services and will be billed separately, but only to the extent that BRAVO has obtained the client’s prior written approval of such costs before incurring such costs.
Compliance Assistance and Management
Since the entry into force of the FSMA regulations, all the big American groups uses web portals to manage the food safety requirements relevant to merchandise bought from foreign suppliers. Therefore, in order to obtain the FSMA compliance status, a supplier/seller that intends to operate in the US must open account on a web portal and upload information, data, and documents related to the food safety practices implemented at its facilities.
Bravo Compliance assists you in opening and managing a dedicated account on your American clients’ portal, and obtaining and updating your FSMA compliance status on there.
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Dedicated access to the Bravo Compliance portal for the management and monitoring of your firm’s FSVP program.
Bravo Compliance provides the user with a dedicated access to customized solutions to manage and/or monitor the compliance with the FSVP regulations
Bravo Compliance Portal is the solution for managing the food safety compliance status. It makes the FSVP online procedure easy, safe and fast while enabling the supplier to communicate with its FSVP Agent on a user-friendly cloud panel. Based on a simple framework, Bravo Compliance enables the user to reach full compliance with the FSVP requirements.
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Dedicated access to the Bravo Compliance portal for the management and monitoring of your firm’s FSVP program.
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Or choose
Our Bravo Packages
Our PACKAGES
to export to the US
Starter
from $270/month
Bravo Compliance offers the Starter Package to foreign firms in their start-up phase with less than 10 shipments per year. The Starter Package is the perfect solution for small exporter company to save on single services while receiving full technical-regulatory guidance to comply with the FSMA regulations.
Business
from $520/month
Bravo Compliance offers the Business Package to small importers or foreign suppliers with less than 25 shipments per year. The Business Package is the perfect solution that enables the small importers and/or exporter company to save on single services while receiving full technical-regulatory guidance to comply with the FSMA regulations as required by the FDA.
Premium
from $850/month
Bravo Compliance offers the Premium Package to the US importers or foreign suppliers performing 25 or more shipments per year, The Premium Package is the solution that enables the exporter to save on single services while receiving full technical-regulatory guidance to comply with the FSMA regulations as required by the FDA.
Do you want to exhibit your products
at a Trade Show in the US?
Do you want to sell
your products online?
Y
Bravo Compliance can follow you in all the steps necessary to sell your products in the United States
To import into the US
F.A.Q.
Is it mandatory for the foreign supplier to retain an FSVP agent to export to and import into the US your food products?
Yes, it is a mandatory requirement if there is not a US owner or designated receiver when your products enter the US borders. The same requirements also apply in case you intend to expose your food products at American trade fairs, or ship them through Amazon to a public storage facility in the US and from there enter the local markets with your own local distribution network.
Is it mandatory for Is a foreign producersupplier that imports its food product into the US to retain an FSVP agent, if that firm dispose of an own US subsidiary company/division registered in the US?
Not necessarily.
However, if the aforesaid US subsidiary company/division does not dispose of personnel professionally familiar with the FSVP regulations and qualified for the role, it does need to retain a qualidied FSVP Agent
Who is qualified to act as an di agente FSVP agent?
A qualified FSVP Agent must be a US-resident professional specifically competent in the FSVP regulation, formally retained by the foreign exporter/FSVP importer to check and ensure that all the food products imported into America by the firm comply with the relevant US laws and can pass the FDA food safety controls.
Is the FSVP Agent obliged to designate a FSVP Qualified Individual?
Yes, it is.
Pursuant to the FSMA relevant dispositions, upon its designation, the FSVP Agent must designate an FSVP Qualified Individual for Prevention Controls (PCQI) as its assistant in drafting, monitoring, and keeping updated the importer’s FSVP Manual.
Which activities must the FSVP Agent perform?
The standard requirements to pass the foreign supplier verification programs (FSVP) are as follows:
- Providing risk analyses for all products to be imported into the US;
- Evaluating and approving foreign suppliers in consideration of their production processes, singles ingredients used in such processes, and categories of products to be imported into the US;
- Pinning down and implementing the verification activities specifically relevant to each and any foreign suppliers;
- Implementing correction procedures (when necessary);
- Representing the importer in the identification procedure when the shipments enter the US and acting as the official record keeper of the importer before the FDA for all the documentation and register keeping relevant to the FSVP regulations for a minimum period of two years;
- Subsequent foreign supplier’s evaluations and approvals (with at least triennial frequency).
What the FSVP Agent is supposed to ensure with is activities?
The FSVP Agent must ensure that all the food products to be imported into the US satisfy the same food safety regulatory requirements which apply to the American producer and distributors. Also, the FSVP Agent needs to specifically verify that the products comply with the US regulations aimed to sanction sophistication and/or improper labeling with respect to allergens.
Which activities is the producer supposed to carry out to comply with the FSMA regulation?
The producer must draft a HARPC (Food Safety Plan) containing the following documents:
- A Risk Analysis aimed to pin down the possible hazards requiring preventive control.
- A certification attesting the preventive food safety controls performed at the production facility.
The Food Safety Plan includes preventive controls on the following areas of interest:
Production processes; hygiene and allergens controls; foreign supplier verification plan, along with a product recall plan from the American market; implementation of the aforesaid preventive controls and corrective/verification procedures.
What happens if my labeling set does not comply with the US rules?
Two options are available to the firm: Either correctly relabeling the products to keep marketing them within the US, or shipping them off the US, or destroying them at its own expense. Labeling incompliance constitutes one of the most common causes of block of sales which the FDA imposes, as well as the consequent product recall by the firm that undergoes the sanction.
What happens if a producer does not comply with the US laws and regulations?
A producer who is not compliant with the regulation PCHF of the FSMA and undergoes a FDA inspection, may incur the block of the product when the merchandise is still in the phase of importation into and/or recall from the American market. A producer, to be sure to obtain customs clearance and marketing feasibility in the States for its human food products, needs to demonstrate that its firm does meet the requirements and dispositions set on the FSMA.
What happens if a producer does not comply with the FSMA regulations?
A producer who is not compliant with the regulation FSVP of the FSMA and undergoes a FDA inspection, may incur the block of the product when the merchandise is still in the phase of importation into the US, and/or in the phase of recall from the American market. A producer, to be sure to obtain custom clearance and marketing feasibility in the States for its human food products, needs to demonstrate that its firms meets can meet the requirements and dispositions set on the FSMA.
Y
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