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FDA

FDA Registration and Certification for the Export of Products to the United States of America

The FDA (Food and Drug Administration) is a federal agency of the United States of America Department of Health that mainly deals with the regulation of imports of foodstuffs, medicines, cosmetics, medical equipment and other biological products or derivatives.

Demos offers a comprehensive and professional advice to register your company and comply with the guidelines set by the FDA before exporting any of the regulated products to the U.S.A.

in order to be able to export and successfully market the products of your company in the United States of America compliance with the FDA regulations is essential.  Demos provides consulting  services specializing in all sectors inspected and regulated by the FDA.

Our expertise with FDA matters also focuses on advising important aspects such as the review of compliance with labelling or safety, use and restrictions of the ingredients and food. Other important elements that are part of our work as consultants are:

  • Compliance Standards of the FDA for Canned Foods, Products of Low Acid or Acidified Foods.
  • Records of New Ingredients and Verification of Possibility of their Use.
  • Prior Export Notifications and Web Entries.
  • Verification of Additives, Dyes, Exempt and Natural.
  • Verification of Raw Materials and Machinery in Contact with Food.
  • Verification of the Program of Substances in Contact with Food.

 

 

A high percentage of the population in the U.S.A.  take a dietary supplements on a daily basis. The FDA requires regulatory compliance from companies exporting to the U.S.A.  this type of product. This federal agency has established quality standards for dietary supplements to ensure their composition, thus preventing the possibility of contamination to users. Demos offers advisory services aimed at:

  • The Company's Records of Dietary Supplements to the FDA and the Registered Agent Service.
  • Verification of Compliance with Product Labels, Ingredients and Substances in Products of Dietary Supplements.
  • Verification of Product Categories: Food Supplements, Medicinal Plants, Functional or Other.
  • Prior Notification Procedures and Intent to Sell the Product in the U.S.A.
  • Subsequent Notification of the Sale of Dietary Supplements in the U.S.A.

If you have a company outside of the U.S.A.  and you want to export your cosmetic products to the United States of America, our expert team of consultants  is your best solution.  Demos will assure the guidelines set by the FDA for cosmetics in terms of labelling, registration and sale of your products for this sector. Your products will be in compliance with the regulations issued by the FDA  which will prevent potential rejection of your products and assist the development of  your business activity with total guarantees.

Demos will advice on the following FDA Regulations for Cosmetics and Medicines:

  • Company Records for the FDA as Manufacturers of Cosmetics and OTC.
  • Review of Product Labels.
  • Verification of Ingredients, Uses, Restrictions. What Makes the Product a Cosmetic or an OTC.
  • Product Records and Obtaining of NDC (National Drug Code).
  • Review and Preparation of GMP (Good Manufacturing Practices) Manual and Verification Processes for Validation of Ingredients.
  • Review and Preparation of SOP (Standard Operating Procedures).

Medical equipment is also a regulated sector of by the FDA. This federal agency defines this type of equipment as tools, machines, implants and other articles made for diagnosis, treatment, or prevention of diseases. Demos can advise you on the FDA regulations for medical equipment in different categories, depending on the risk involved. Our consulting services are focused on:

  • Company Records with the FDA and Registered Agent Service.
  • Classification of Medical Equipment (Class I, II, III).
  • Records of Medical Equipment (WFP, 510K).
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