Who we are.

We help businesses across food, agriculture, pharmaceuticals, cosmetics, dietary supplements, medical devices, chemicals and related sectors navigate USFDA and international regulatory requirements, resolve import alerts, and prevent shipment refusals.

Regulation read as a working problem

Most compliance failures are not a matter of intent. They come from a record that does not say what the regulation expects it to say, a control that was never written down, or a supplier whose paperwork was never verified. We start by finding which of those it is, then rebuild the file so it holds up on review.

Our work is documentary and operational at the same time: the plan a regulator reads has to be the plan the plant can actually run.

Exporters, manufacturers and their counsel

Producers and processors shipping into the United States, manufacturers preparing a first entry, and importers of record who need a supplier programme that survives an audit. We are asked in when a shipment is detained, when an inspection has raised observations, or before a new market opens and the labeling, records and procedures still have to be built.

We work in English and Spanish, with teams in Latin America and counterparts in the United States.

Where our scope ends

We prepare; your firm files. We are not your United States Agent and we do not sign or submit to FDA on your behalf. We draft the petition, build the corrective action file and coordinate the laboratory work; your firm or its United States counsel submits it and holds the correspondence with the Division of Import Operations. We stay behind that correspondence, drafting the responses.