Services

We assist foreign manufacturers with FDA facility registration for food, dietary supplements, cosmetics, and related regulated products. Our team guides you through the complete registration process, including account setup, data verification, and official submission through FDA systems. We carefully review all facility and ownership details to minimize errors and prevent delays. By ensuring accurate and timely registration, we help your business establish a compliant foundation for exporting to the United States.

Includes:
✔ New facility registration
✔ Account setup and configuration
✔ Data verification
✔ Official submission
✔ Confirmation records
✔ Renewal preparation

We provide reliable U.S. Agent representation for foreign manufacturers required to appoint a U.S.-based contact for FDA communications. As your designated agent, we receive regulatory notices, inspection-related messages, and official correspondence on your behalf. Our team promptly forwards communications and explains required actions in clear terms. This ensures that important regulatory matters are handled professionally and without delay, protecting your compliance status.

Includes:
✔ U.S. Agent designation
✔ FDA communication handling
✔ Inspection coordination
✔ Regulatory guidance
✔ Secure recordkeeping

Our U.S. Market Entry service helps businesses prepare for successful entry into the American market through structured regulatory planning and compliance support. We review your products, business model, and export goals to identify applicable FDA requirements. Our team provides guidance on registration, labeling expectations, documentation, and import readiness. This service helps reduce shipment risks, avoid costly mistakes, and build long-term export confidence.

Includes:
✔ Product classification review
✔ Regulatory mapping
✔ Registration planning
✔ Labeling guidance
✔ Import readiness support

We manage FDA renewals, updates, and compliance monitoring to ensure your registrations remain active and accurate year after year. Our team tracks regulatory deadlines, verifies facility information, and submits renewals on time through official systems. We also monitor regulatory alerts and notify you of changes that may affect your business. This proactive approach helps prevent inactive status, shipment delays, and regulatory penalties.

Includes:
✔ Renewal scheduling
✔ Deadline tracking
✔ Information updates
✔ Compliance monitoring
✔ Documentation management

We provide practical guidance on labeling formats and regulatory documentation requirements for U.S. market entry. Our service includes reviewing ingredient listings, product identity statements, and required information to help you understand compliance expectations. We also assist with import documentation and marketplace readiness requirements. Proper labeling and documentation reduce the risk of customs holds, rejections, and distribution issues.

Includes:
✔ Ingredient listing guidance
✔ Label format review
✔ Required information checklist
✔ Import documentation support
✔ Marketplace readiness

We offer personalized regulatory consulting for businesses with complex compliance needs, expansion plans, or multi-product operations. Our advisory services include regulatory assessments, compliance gap analysis, and long-term planning support. We help clients navigate changing regulations, manage multiple facilities, and adapt to new market opportunities. This service is designed for businesses seeking strategic, long-term regulatory guidance.

Includes:
✔ Regulatory assessments
✔ Compliance gap analysis
✔ Expansion planning
✔ Multi-facility support
✔ Strategic advisory