The FDA regulates drug products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of humans or animals. DDC provides all the services to help you comply with the law.
Servicio de etiquetado de medicamentos e ingredientes:
By FDA rules drug labels must be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. DDC provides this service to help you comply with the rules.
Listing of products and Registered Agent:
Owners or operators of foreign drug establishments: manufacturing, preparation, propagation, compounding, or processing of drugs are required to register and submit a list of every drug in commercial distribution in the US.
1800€ (Annual fee)
Listing of products: €550 USD per product.
FDA Drug Master Files (DMF):
A Drug Master File is a submission to FDA that is used as a support document of pre-market submissions to provide confidential and detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of the product.
Operators of facilities that produce generic drugs and generic drug APIs must submit “self-identification” information to FDA between May 1 and June 1 of each year.
FDA considers a drug color additive any dye, pigment, or other substance that can impart color to a drug product.
If your product is of interest to us, we may open the market for you in exchange of commissions on sales.
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