Regulatory Logistics Services

FDA Initial Importer Program Management

We establish and manage your Initial Importer obligations, ensuring your supply chain meets FDA's accountability requirements.

Prior Notice Filing for Imported Products

We submit Prior Notice filings to FDA before your shipments arrive, preventing holds and delays at the border.

Import Alert Investigation & Removal Petitions

We investigate the root cause of import alerts and prepare detailed petitions to FDA to restore your importing privileges.

FDA-Registered Warehousing & Distribution

We connect you with FDA-registered storage and distribution facilities to keep your supply chain fully compliant.

U.S. Agent Designation Services (21 CFR 807)

We act as your designated U.S. Agent for FDA communications — a requirement for all foreign device manufacturers.

Certificate to Foreign Government (CFG) Requests

We prepare and submit CFG requests, providing official FDA documentation to support your exports to international markets.

FDA Recall Management & CAPA Support (21 CFR Part 7)

We manage voluntary recall logistics and prepare CAPA plans to address the root cause and satisfy FDA requirements.

Customs & Trade Compliance for FDA-Regulated Products

We advise on import documentation and trade compliance requirements specific to FDA-regulated products.