FDA Registro de Medicamentos | Asistencia Regulatoria FDA para Compañías de Alimentos, Aparatos Médicos, Medicamentos & Cosméticos

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New Electronic System Over-the-Counter Prescription Active Pharmaceutical Ingredients Homeopathic Drugs Archivo Maestro de Medicamentos (DMF)Label Reviews

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Medicamentos
The United States FDA regulates products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body of man or other animals. Registrar Corp provides Registration, Update, and Renewal assistance for U.S. and Non-U.S. companies in the Drug industry.

If already registered with FDA
Elija AquÃ	As of June 2009, drug registrations, listings, annual renewals and updates must be submitted to FDA electronically. Drug labels must be indexed using extensible markup language (XML) in SPL format. To register or renew, drug establishments must provide DUNS numbers for their private label distributors, manufacturers and importers. The new requirements apply to Over-the-Counter Drugs, Active Pharmaceutical Ingredients, Prescription Drugs, Homeopathic Drugs, and Animal Drug Products. Registrar Corp can assist you to quickly and easily transition to FDA's new electronic drug system.

If not yet registered with FDA
Elija AquÃ	Registrar Corp can assist with registrations, listings, U.S. Agent requirement, and Drug label submissions.

Regulaciones Americanas Aplicables:

FDA Regulation: 21 C.F.R. Part 207

Registrar Corp asiste a las compañías a cumplir con la FDA. Los Certificados de Registro expedidos por Registrar Corp provean confirmación a las industrias de que estas cumpliendo con los requisitos de registro de la FDA. La FDA no expida ni reconoce los Certificados de Registro. Registrar Corp no está afiliado con la Administración de Comida y Drogas de los Estados Unidos (FDA).


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