US Representative
FDA Authorized Agent

FDA US Agent

The United States Food and Drug Administration (FDA) requires foreign medical and health product manufacturers without a location in the United States to appoint a US Agent. The appointed agent must be a US resident and maintain a place of business in the US. The US Agent will serve as a liaison between your company and the FDA.

Sigma Biomedical serves as liaison and agent and communicates with the FDA on behalf of customers. Services include responding to FDA communications with respect to your products and records, be a point of contact for urgent matters, providing you support in responding to FDA questions and concerns, and discussing compliance with FDA regulatory mandates as well as product listing and registration needs.

FDA Regulatory Consultant

Sigma Biomedical is also serving international customers establishing a business office in the US. Services include company incubation, business administration, logistics, marketing, inventory and distribution, as well as implementation of quality management systems for FDA compliance. We also offer virtual offices equipped with live receptionist, mail room and conference room facilities, as well as dedicated office space in our premises. You can benefit from our low-cost office solutions dedicated to biomedical and biotechnology businesses.