What is FDA?
Food and Drug Administration (FDA) is responsible for the regulation and supervision of the safety of food, dietary supplements, medicines, vaccines, medical devices, veterinary products, and cosmetics.
The FDA is a standard that primarily aims to improve the quality and health safety of foods, supplements, cosmetics and pharmaceuticals, vaccines, veterinary drugs, medical devices, and tobacco products manufactured both in the United States and throughout the world.
According to the regulations, these products can be approved for sale on the market after passing FDA tests to prove their safety. The FDA doesn’t just issue certifications. It constantly conducts clinical research and monitors the quality of the results. The department has the power to revoke its certifications if the quality of the results does not meet the high FDA requirements. In the US, it is the FDA that controls most food products. Once food contact materials are tested, they become more competitive and more profitable.
What is subject to certification?
- Food and nutritional supplements
- Medicines and vaccines
- Honey and beekeeping products
- Cosmetics
- Veterinary drugs
- Animal feed
- Alcoholic drinks (alcohol content <7%)
- Electronic products
- Tobacco products
- Radiation products
- Other products that are related to human health
Our FDA Registration Services:
1. For food manufacturers – FDA registration of manufacturers, labeling, FDA US Agent services, development of safety and GMP plans for the supply of food and dietary supplements to the US market.
2. For Animal Feed Manufacturers – Registration of animal feed with US state authorities, FDA labeling, and other services for supplying animal feed to the US market.
3. For manufacturers of medical devices – the definition of the class of medical products, registration of medical products according to FDA and other notified bodies, other services for the supply of medical devices to the US market.
4. For manufacturers of cosmetic products – Registration of manufacturers and cosmetic products under the FDA VCRP program. Label analysis and design, other services for the supply of cosmetic products to the US market.
Our knowledge and experience in securing product supply in the United States will allow you to fulfill all the necessary requirements and pass FDA registration and receive other services with minimal cost and in a short time.
General procedure for performing work in the field of FDA registration:
- You apply to Star-Drive for registration.
- Our experts evaluate the information received and determine the necessary stages of work, which will differ depending on the type of product and other factors.
- You enter into an agreement with a representative of the manufacturer in the United States (Official U.S. Agent), product information is registered in the U.S. register. FDA, which is a prerequisite for the import of products.
- If necessary, Star-Drive experts ensure the correct labeling of your products supplied to the United States (if the labeling does not meet the requirements, the products will not pass customs check and their import will be refused!)
- If the FDA decides on the need to check your production, Star-Drive ensures that you meet the requirements for production and products (implementation of GMP requirements, etc.), as well as organizes laboratory testing of products in a recognized and accredited laboratory, passing certification and organization of registration of your products in the FDA.
By contacting Star-Drive you will receive:
- Qualified assistance and advice on the certification and registration of the FDA
- Prompt and guaranteed registration of products with the FDA (from 3 working days)
- Withdrawal of a binding agreement for FDA registration with an authorized agent of a foreign manufacturer in the United States (U.S. Agent),
- Ensuring that the labeling of products imported into the United States meets legal requirements.
- Preparation, if required by the FDA, of the production for an assessment at the location of the manufacturer (GMP requirements, etc.)
- Organization, in the case of FDA requirements, laboratory testing in recognized laboratories
- Organization of contacts with the FDA at all stages of preparation and certification and registration with the FDA
- FDA training for employees
- Support after the completion of the certification and registration procedure (including regular laboratory tests and scheduled audits).
- Certification of your company’s management system according to ISO:9001, ISO:14001, and other standards according to the national accreditation of the USA – ANAB, which will allow you to gain additional competitive advantages in the US market.