FDA Registration

 A drug broadly speaking, is any substance that when administered into the body either Internal or external for treatment, mitigation or prevention of any disease or disorder in a living organism which can alters normal bodily function.

There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.

Cosmetics are substances used to enhance the appearance of the human body. Cosmetics can be rubbed, poured, sprinkled or sprayed on, or introduced into the human body or any part thereof for the above said purpose, and includes any article intended for use as a component of cosmetic.

United States Federal Food, Drug, and Cosmetic Act, as per section FDA 510 K requires manufacturers, Repacker, and relabels that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products must register their establishment(s) and submit a listing of every product in commercial distribution.

Drug establishment registration and drug listing done online by US Agent. From 1^st of June 2009 onwards FDA not accepting paper submissions for drug registration and drug Listing. Electronic system which will improve the timeliness and accuracy of the submissions.

I3CGLOBAL provides following FDA Drug establishment Registration and listing related service. Drug establishment registration, Labeller code, DUNS processing, US Agent, Drug Listing, Label Review (optional), In SPL format (preparation and submission)