Registro con la FDA

Registro de medicamentos de venta libre (OTC)

 Todos los medicamentos de venta libre deben registrarse a través del portal de presentación electrónica de la FDA. Para los importadores, el fabricante no solo debe tener un registro de fábrica, sino que también lo hace el importador. En Capote Law Firm manejamos a través del registro de instalaciones, solicitud de código de etiquetadora y listado de medicamentos para asegurar que su compañía se registre exitosamente para hacer negocios bajo las regulaciones de la FDA.

Dispositivo médico

 ¿Su empresa está registrada en la FDA como fabricante, distribuidor, importador inicial o reempaquetador de dispositivos médicos? ¿Ha permitido que caduque su registro? Capote Law Firm revisará el estado de su producto, le proporcionará la orientación reglamentaria necesaria y asegurará que su instalación esté registrada y que la lista de dispositivos esté actualizada.

Cosméticos

 La FDA tiene un registro voluntario y un sistema de listado de ingredientes para los fabricantes, distribuidores e importadores interesados ​​en proporcionar a la FDA información sobre sus fábricas y los ingredientes que se utilizan en sus productos. Capote Law Firm ayuda a los clientes a proporcionar la información de registro necesaria bajo el programa de registro voluntario.

AV Rated

Our attorneys are AV rated since 2012 and bilingual. They have been recognized by Daily Business Review as Top Lawyers and selected as Florida Bar Wm. Reece Leadership Academy Fellow.

Dedicated

We are dedicated to providing the most responsive client experience. We learn about your business to provide you with the business approach to regulatory compliance that works best for you.

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