Registration with the U.S. Food and Drug Administration

FDA Registration for all industries.

 

Food Facility Registration and Re-Registration

According to the United States Food and Drug Administration FDA, all facilities that manufacture, process, pack and store food, beverage and dietary supplements that are marketed in the U.S. must register with FDA. In order to be registered, companies that are based outside the U.S. must have a U.S. agent assigned that will be FDA’s primary point of contact on behalf of a foreign company. Fill this fom regarding FDA Food Facility Registration.

 

FSVP Service Request

FSVP is a risk-assessing program developed under to FDA’s Food Safety Modernization Act of 2011, also known as “FSMA”. FSVP requires verification of the foreign suppliers of food items entering the U.S., and it demands conduction of procedures and actions to assure the safety of food exported to the United States. If you are a trader, broker or manufacturing company and need an FSVP agent to take the responsibility of the FSVP program for a food shipment, depending on the nature of food items entering the U.S., we can serve as FSVP agent for your company.

FCE/SID Initial Product Assessment

Its not always easy for FDA to determine if your food and beverage products need a FCE/SID submission or if they are excluded. However in order to stay away from costly FDA import detentions it is important to speak to FDA consultants who have the knowledge of this area. If you are curious to determine if your product is LACF or AF or ​excluded from submission, Please fill the form to ask for our FCE/SID expert service for a free initial assessment.

Food Canning Establishment Registration (FCE), Renewal & Submission Identifier (SID)

If you are a Acidified or Low-Acid Canned Food manufacturer, Viva FDA will help your company to ensure that your Food Canning Establishment is correctly registered with FDA and your scheduled process for each product is properly declared and filed. By using our FCE SID service you get access to free expert consultations for your new products for one full year.Fill this form to proceed with FCE/ SID registration .

FDA Food, Beverage and Dietary Supplement Labeling Review

Viva FDA labeling regulation experts who have an extensive background with providing FDA compliant labeling requirements will first analyze your current label by cross-checking against relevant U.S. federal regulatory databases and FDA labeling guidelines. This will encompass the modification considerations. Next, we will provide you with comprehensive detailed product-specific labeling report and a ready-to-print label (bilingual if necessary) for your food, beverage and dietary supplement products. Fill the form for free initial labeling assessment and expert FDA compliant labeling review.

Shipment’s Prior Notice

U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filled by international transit firms as well as shipment companies (DHL, FedEx, TNT, etc). Fill this form to inquire about Prior Notice options available to you.

Color additive Review and Batch Certification Services

Viva FDA assists companies in demonstrating to FDA that the color additives used in their manufacturing process are certified, and approved by FDA. We initially provide you with an assessment of your color additive to determine if batch certification is needed or not. If so, our experts we will assist you through filling for batch certifications and the approval process. For assistance regarding color additive review and batch certification fill the form.

 

Medical Device Establishment Registration and Device Listing

Viva FDA provides FDA medical devices establishment registration and medical device Listing and can act as U.S. FDA Agent to Non-US companies that are already in the market or intending to enter the U.S. market. Fill this form for medical devices establishment registration and device listing.

 

FDA Medical Devices Labeling Requirements

Labeling issues are often the primary cause of delays in FDA approval and import detentions. Viva FDA team of device labeling experts who have an extensive background in providing labeling reviews will first analyze your label by cross checking it against relevant U.S. federal regulatory databases and FDA labeling guidelines. Next, we will will provide you with comprehensive FDA compliant labeling review of your medical devices. The review will be provided in an all-inclusive report format that will include the suggested graphic design and the claim modifications that are ready to be used on the product. Fill this form to request for free initial labeling assessment and expert FDA compliant device labeling review.

FDA GUDID submission and UDI assistance

Viva FDA can assist you in deciding if FDA’s UDI is required for your device as well as submitting your device information to FDA’s Global Unique Device Identification Database (GUDID). Fill this form for free initial assessment and GUDID submission and UDI assistance.

FDA 510(k) Preparations and Submissions assistance

As a device manufacturer or distributer you may carry the uncharted scientific material necessary for 510(k) submission. However, Viva FDA will assist you with 510(k) filling preparation to ensure all required FDA formats and necessary elements are fulfilled and are FDA compliant before submitting the 510(k) on your behalf. Fill this form for 510(k) submission assistance.

FDA Cosmetic Establishment Registration and Cosmetic Product Ingredient Statements (CPIS) Filing

Viva FDA will assist cosmetic manufacturers or packers whose products are in commercial use to register their cosmetic establishments with FDA (Cosmetic Manufacturing Establishment Registration). Viva FDA also helps cosmetic manufacturers, packers, or distributors to file a statement for each cosmetic product (Cosmetic Product Ingredient Statements, CPIS) the firm has entered into commercial distribution in the U.S. Fill the below form for FDA Cosmetic Establishment Registration and Cosmetic Product Ingredient Statements (CPIS) Filing

California Safe Cosmetics Program (CSCP) Requirement Assistance

For all cosmetic products sold in California, the CSCP program requires the manufacturer, packer, and/or distributor named on the product label to provide a list of all cosmetic products that contain any ingredients suspected to cause cancer or developmental or other reproductive harm. Viva FDA can help you determine if you are subject to CSCP reporting system and prepare and submit the cosmetic products fillings that are required by the state of California. Fill the form for California Safe Cosmetics Program (CSCP) Reporting assistance.

Cosmetic Labeling and Ingredients FDA Compliance Review Assistance

Labeling issues are often the primary cause of delays in FDA release or import detentions. Viva FDA cosmetic labeling review experts will will first analyze your label and ingredients (chemical entities, intended use, FDA restrictions, etc) by cross checking against relevant U.S. federal regulatory databases and FDA labeling guidelines. Next we will provide you with comprehensive ingredient, labeling and modification report and a ready-to-print label for your cosmetic products. Fill this form to request for free initial labeling assessment and new FDA compliant cosmetic labeling requirements.

Drug Establishment Registration FDA Drug Listing

According to the United States’ Food and Drug Administration, U.S. FDA Drug Regulations, all drug establishments that formulate, develop, manufacture, process or pack drugs that are marketed in the U.S. must register with FDA. Furthermore, all drug establishments that formulate, develop, manufacture, process or pack drugs that are marketed in the U.S. must list all of their marketed products through Electronic Drug Registration and Listing System (eDRLS). Fill this from for assistance.

FDA Drug Labeling and Ingredient Requirement

Labeling issues are often the primary cause of delays in FDA approvals, import alerts and detentions. Viva FDA drug labeling experts will first analyze your label by cross checking against applicable U.S. federal regulatory databases and FDA labeling guidelines. Next, we will will provide you with comprehensive FDA compliant labeling review in an all-inclusive report that suggests the proper format and is ready to be used on the drug packaging. Fill this form to request for free initial labeling assessment and FDA compliant drug labeling review.

 

Contact Us

For general and all other inquiries please contact us here.