FDA US Agent Services
HartmannWillner LLC provides FDA US Agent services to foreign (nonUS-based) companies. These FDA US Agent services allow a company to file submissions with the Food and Drug Administration (FDA) and to register their establishment engaged in the manufacture of a drug or device imported into the US. These submissions include pre-IND meeting materials, INDs, BLAs, NDAs, ANDAs, Master Files and Orphan Drug Designation (ODD) requests. They are described in FDA regulations 21 CFR 207, 312, 314, 316, & 807.
Our FDA US Agent services include assisting in FDA communication with the foreign establishment, responding to FDA questions concerning the foreign establishment’s biologics, drugs or devices that are imported into the United States, and assisting FDA in scheduling inspections of the foreign establishment. If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the FDA US Agent – this action is considered to be equivalent to providing the same information or documents to the foreign establishment.