FDA Drugs

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Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA and must appoint a U.S. Agent.

Manufacturers of drugs to be imported into the U.S. from a foreign country also need to list all their marketed drug products. The compliance of drugs being sold to customers in the U.S. – whether it is over the counter or prescription drugs, including generic drugs and homeopathic therapeutics must be verified. This way, the drug products that enter the U.S.-market can be labeled as ‘safe’ as they comply with the applicable label requirements as established by the FDA. This means that if you are a drug manufacturer from a foreign country, and you would like to market your drugs in the U.S., these pharmaceutical goods must meet certain requirements, and you have completed your FDA registration.

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Drugs

Meeting the Requirements for Drugs to Enter the U.S. Market

The FDA is responsible for preserving and protecting the public health of American citizens. Drugs must meet a list of requirements before they can be labeled as safe, wholesome, and/or sanitary. All human and veterinary drugs, vaccines, and all kinds of other homeopathic products and medical devices that are intended for human use must be safe and effective. 

TABS offers FDA compliance, including FDA agent and support services concerning the registration of drugs, so foreign manufacturers are aware of the requirements of the drug and can be offered the right assistance for entering the U.S. market. 

We offer various programs focused on FDA compliance and meeting the requirements for drugs that are valid in the U.S.:

  • Annual certification and renewal establishment registration
  • Initial drug establishment registration, listing, and U.S. agent
  • Update of drug listings

So, if you are a foreign manufacturer of drugs looking to expand your business to the U.S. market, we are a U.S. FDA Agent that will gladly assist you in completing your FDA registration and help you understand and comply with the requirements for drugs. 

Contact our team of professionals to learn more about our FDA services
Are you a drug manufacturer from a European country, and would you like to know more about FDA compliance, the requirements for the Initial Drug Establishment Registration, Listing & U.S.- Agent, the updating of drug listing, and other support services concerning FDA requirements? TABS will gladly provide you with all the information you need, so you will soon be able to explore and tap into the U.S. markets without being held back by administrative and regulatory challenges. This way, you can successfully look forward to expanding your business and growing your company overseas. Contact us. Our FDA team looks forward to being of service.

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