Is this package only for FDA-regulated products?

No. It’s designed for U.S. importing generally, but it’s especially valuable when your products are FDA-regulated and need extra compliance work alongside shipping and clearance.

Do you provide customs brokerage directly?

We provide customs documentation and clearance support, and we can coordinate customs brokerage/entry filing where needed as part of the package—so the workflow stays joined up.

What FDA compliance items are typically included?

• Depending on product category and your business model, this can include registration/agent support (where applicable), labeling checks, Prior Notice support, and FSVP documentation support (where applicable).

Do I need Prior Notice?

• Food, beverages, and dietary supplements commonly require FDA Prior Notice before arrival. We’ll confirm what applies to your shipment and support the filing as needed.

Can you help if my shipment is already delayed or detained?

Yes. If a shipment is held, we’ll review the reason, identify what documentation or corrections are needed, and support the response workflow.

How do you price the Full U.S. Importing Package?

Pricing depends on product category, shipment frequency, and complexity (e.g., number of SKUs, suppliers, and whether ongoing support is needed). We’ll scope this quickly on a call.

I’m a non-U.S. company—can I still import into the U.S.?

Often yes, but you may need an in-country structure depending on product type and importer responsibilities. If an Importer of Record solution is required for your model, we can discuss options.

Can you support ongoing monthly shipments?

Yes. Many clients use this package as an ongoing program so each shipment follows a repeatable, documented process.

Full US Importing Package for FDA Compliance

Overview

Service overview

We coordinate your freight, FDA requirements and customs clearance as one managed workflow, from registration and Prior Notice to entry documents.

Export-ready goods prepared inside a warehouse

Why this service matters

US imports involve three workstreams: logistics, FDA compliance and customs clearance.
Delays usually come from missing details, such as incomplete documents or a late filing.
Checking requirements before shipping avoids fixing problems at the port.

How We Keep Your US Imports Moving

Shipment delays usually come from missing details, such as the wrong product description, incomplete documents, a label issue or a filing made at the wrong time.

Build a single plan for logistics, compliance and clearance
Identify whether your product is regulated by the FDA, USDA or another agency
Confirm what needs to be done before shipping, so you don't fix it at the port
Prepare and manage the documentation needed for customs and FDA entry
Support ongoing imports with repeatable, audit-ready records

Cargo containers moving through an international port — IoR & Other Services
Full U.S. Importing Package for FDA Compliance

What's Included at a Glance

The package brings three workstreams together in one coordinated workflow.

Logistics: freight coordination, shipping documents and delivery scheduling
FDA compliance: registration and agent support, labelling checks, Prior Notice and FSVP support (where applicable)
Customs clearance: document preparation and review, product data readiness, and coordination with brokerage and entry filing as needed

FSVP Role Clarity

Under FDA's FSVP rule, the FSVP Importer is the US owner or consignee of the food at entry, which is not always the party acting as Importer of Record for customs.

Identifying the correct FSVP Importer for each shipment or product
Drafting and managing statements of consent when there is no US owner or consignee
FSVP programmes developed and performed by a Qualified Individual (QI)
Record readiness for FDA requests, including portal submissions when requested
Keeping your FSVP aligned to FDA's risk-based expectations

US Import Compliance Support

If your product is FDA-regulated, shipping it is only half the job; the other half is showing compliance, often before your goods arrive.

FDA facility registration and US Agent or point-of-contact support (where required)
FSVP support and audit-ready documentation for food and dietary supplements (where applicable)
FDA Prior Notice filing support for food, beverages and dietary supplements
Label checks for food, supplements and cosmetics to reduce compliance risk
Customs documentation aligned to FDA entry requirements, with detention response support if issues arise

Our Process

We take each shipment through five steps, from product intake to arrival.

1
Import plan and product intake: we review product type, ingredients or materials, intended use, manufacturing details and shipping lanes, then map the compliance and clearance steps before you commit to a shipment timeline
2
FDA compliance setup: registration and agent support, label and claims checks, Prior Notice and FSVP support, depending on your product category
3
Customs documentation and clearance: document preparation and review, data consistency checks, HS/HTS classification inputs and coordination with brokerage or entry filing
4
Logistics coordination: freight (air, ocean or road) and handoffs, shipping documents collected and checked, and delivery scheduling
5
Arrival, exceptions and detention support: if a shipment is held, we help you respond with the right documentation and corrective steps

Before-You-Ship Checklist

A Full US Importing Package keeps the shipment, filings and documents aligned from origin to US entry, starting with these checks.

Confirm the product category (food, supplement, cosmetic, device or other regulated product) and check label format and required statements
Make sure manufacturer and facility details are consistent across documents
Prepare the commercial invoice and packing list with clear product descriptions
Confirm any required FDA filings (e.g. Prior Notice for food and supplements) and who is responsible for clearance (importer, consignee or broker)
Align shipping timelines with filing timelines and document availability

Other Ways We Can Help

Alongside the full package, we offer targeted support for specific import needs.

Detention and compliance issue resolution, with corrective documentation for FDA or customs holds
Importer of Record support if you don't have a US entity, depending on your model and product category
Ongoing monthly or quarterly support for brands shipping regularly to the US
A role map of your current shipping model (Incoterms, consignee, broker) showing who is IOR, FSVP Importer and QI, and which documents should exist

Ongoing compliance support

Time-Saving
One team coordinates shipping, compliance and clearance, so you aren't managing three projects.
Regulatory Assurance
FDA and customs requirements are confirmed before shipping, not fixed at the port.
Peace of Mind
Repeatable, audit-ready records support smoother ongoing imports.

What you'll need

Before you ship, pull these together so one plan covers everything.

Product categoryFood, supplement, cosmetic, device or other.
Consistent facility detailsManufacturer and facility data matching across documents.
Invoice and packing listWith clear product descriptions.
Regulating agencyWhether the FDA, USDA or another agency applies.

Full U.S. Importing Package for FDA Compliance