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 must be reported on all the export documents for your merchandise shipped to America.

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FDA Registration
$100 (additional facility) $85

U.S. Agent

Bravo Compliance can be engaged as your US Agent in 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 (non commercial / financial) third-party consultant retained by your firm to communicate with the FDA during the FDA registration procedure.

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FDA Agent (U.S. Agent)

$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 controversies with the FDA.

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US Applicable Laws and Regulation (Requirements check)

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 exposing samples at American trade fairs, as well as trading 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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FSMA Compliance (Compliance check)

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 exposing commercial samples at American trade fairs or trading 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.  

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FSVP Agent per singola importazione (FSVP Agent)

Starting from $165 (additional Entry) $155

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 exposing commercial samples at American trade fairs or trading your merchandise through web portals like Amazon, you need to previously ascertain that the labeling standards for your products meets the requirements set by the relevant US regulations and the description of nutritional data, allergenics, and additives, along with all other futures of your labels, comply with such rules.

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Label Editing and Upgrading (Labeling review)

Starting from $850 (additional Label) $780

Qualified FSVP Contact for FDA Communication

Bravo Compliance can be your FSVP qualified contact for the FDA in the US for any product imported 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 officially retain an FSVP Agent. The latter is an independent qualified professional residing in the US, either a natural or legal person, who acts as a non-financial/commercial representative of your firm before the FDA in the role of contact person for the communications to and from the agency, along with any procedures, and notices concerning your import activities. The Agent monitors and verifies the progressive updating of the FSVP Manual activities, as required by the relevant FDA dispositions. 

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Qualified FSVP Contact for FDA Communication

Starting from $300/month (additional supplier and/or product category) $350

FSVP Qualified Individual (PCQI)

Bravo Compliance can act as your FSVP (PCQI).

The FSVP importer that does not dispose of personnel professionally familiar with the regulatory requirements to be satisfied to successfully complete 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) who will draft the FSVP Manual for the firm, as required by the FDA.

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Foreign Supplier Verification Program (FSVP)

$1.850* (additional product category) $950

*Our offer will be confirmed once viewed the producer’s documentation relevant to the food safety rules compliance.

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 ascertain having implemented the principles of risk analysis and preventive controls at all the stages of the production process based on the HARPC regulation (USA) and NOT on the HACCP regulation (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 FSVP / FSMA

Bravo Compliance can assist you in the context of the FDA audits relevant to your firm’s compliance with the FSMA regulation Foreign Supplier Verification Program.

The importers are supposed to pass an FDA audit to ascertain the correct implementation of the (FSMA) FSVP rules by their firm.

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Hourly Rate for a remote Regulatory Audit (Assistance with FDA Audit in remote mode)

$1.650* (additional product category) $1.600

* 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 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 PCHF / FSMA

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 Foreign.

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) $1.600

* 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 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 Assistence 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.

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Compliance Assistance and Management (U.S. Customers portal)

Contact Bravo Compliance for pricing

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 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.

Contact Bravo Compliance for pricing

Or choose

Our Bravo Pack

C

Our PACKS

To export to the US

Starter

to $275/month

Bravo Compliance offers the Starter Package to foreign firms in their start-up phase (less than 10 shipments per year). The Starter Package is the perfect solution for the exporter to save on single services while receiving full technical-regulatory guidance to comply with the FSMA regulations.

Business

to $475/month

Bravo Compliance offers the Business Package to US importers or foreign suppliers with less than 50 shipments per year. The Business 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.

Premium

to $960/month

Bravo Compliance offers the Premium Package to the US importers or foreign suppliers performing 50 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 show your products

At a Trade Fair 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 to retain an FSVP agent to export to the US?

Yes, it is a mandatory requirement if there is not a US owner or designated receiver when your products enter the US boarders. The same requirements also apply in case you intend to show 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 local distribution network.

Is a foreign producer/exporter with a US subsidiary company/division registered in the US

Not necessarily.

However, if the aforesaid US subsidiary/division does not dispose of a qualified employee professionally familiar with the FSVP regulations, it does need to retain an 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 product imported into America 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 designated a FSVP Qualified Individual for Prevention Controls (PCQI) as its assistant in drafting, monitoring, and keeping updated  the FSVP Manual for the importer, as required by the FDA.

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 the foreign suppliers in consideration of their production processes, singles ingredients used in such processes, and types of  product to be imported into the US;  
  • Pinning down and implement 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 concerning documents and registers relevant to the FSVP regulations for two years or more;
  • Subsequent evaluations and approvals of the foreign suppliers every three year or more.
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.
  • Certification attesting the preventive food safety controls performed at the producer facility.

The Food Safety Plan includes the 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 non does not comply with the US rules?

Two options are available to the firm: Either correctly relabeling the products to keep marketing it in America, or shipping it off the US, or destroyng it at its own expenses. Labeling incompliance constitutes one of the most common cause of block of sales imposed by the FDA and the consequent product recall by the firms.

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 and/or in the process 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 can 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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