FDA Services

MONTHLY SHIPMENT DESK - FDA COMPLIANCE

All Prior Notices are manually prepared and reviewed by a regulatory compliance professional, not generated through automated filing software.

These services are offered through recurring subscription plans designed for companies with ongoing FDA-regulated shipments to the United States.

Each submission is individually analyzed to verify product details, manufacturer information, FDA registration data, shipment information, and potential inconsistencies before filing.

When necessary, corrections and regulatory guidance are provided to help reduce the risk of submission errors, FDA holds, shipment delays, or import detentions.

PACKAGE 1 - BASIC

Basic Shipment Desk
For exporters with low but regular shipment frequency to the U.S.

What’s included:

Up to 3 FDA Prior Notices per month
Each Prior Notice may include up to 12 SKUs
FDA Product Code creation and validation
Correction of inconsistencies and regulatory errors
Basic regulatory review of product descriptions for FDA compliance

This plan is ideal for exporters who ship regularly but want to avoid costly FDA mistakes and detentions while keeping monthly compliance costs predictable.

PRICE: US$ 410 / month

Cost comparison:
3 individual Prior Notices × 170 = US$ 510

YOU SAVE: US$ 100 / month - US$ 1,200 / year!

PACKAGE 2 - STANDARD

Standard Shipment Desk
For exporters shipping multiple times per month with broader product lines.

What’s included:

Up to 6 FDA Prior Notices per month
Each Prior Notice may include up to 15 SKUs
FDA Product Code creation and validation
Comprehensive manual compliance review for every submission
High-level ingredient risk screening
Consistency check against previous FDA Prior Notice submissions
Pre-submission correction to prevent FDA flags and detentions
Ongoing email or WhatsApp support

This plan reduces regulatory risk while supporting growing export operations that require accuracy, consistency, and predictable monthly costs.

PRICE: US$ 780 / month

Cost comparison:
6 individual Prior Notices × 170 = US$ 1,020

YOU SAVE: US$ 240 / month - US$ 2,880 / year!

PACKAGE 3 - ADVANCED

Advanced Shipment Desk
For exporters with high shipment volume who cannot afford delays.

What’s included:

Up to 10 FDA Prior Notices per month
Each Prior Notice may include up to 20 SKUs
FDA Product Code creation and validation
Comprehensive manual compliance review for every submission
Ingredient and formulation risk screening focused on FDA enforcement trends
Historical consistency analysis across all Prior Notice submissions
Pre-submission correction to prevent FDA flags and detentions
Priority internal handling to meet urgent shipment timelines
Ongoing email or WhatsApp support
FDA detention risk prevention review

This plan is designed for mature exporters who need speed, regulatory accuracy, and maximum protection against shipment delays and FDA enforcement actions.

PRICE: US$ 1,150 / month

Cost comparison:
10 individual Prior Notices × 170 = US$ 1,700

YOU SAVE: US$ 550 / month - US$ 6,600 / year!

BE REPRESENTED INTERNATIONALLY - U.S. AGENT SERVICES

A U.S. Agent is mandatory for foreign facilities that manufacture, process, pack, or store FDA-regulated products such as food, beverages, dietary supplements, cosmetics, OTC products and pet products.

This service includes:

✔ U.S. Agent representation;
✔ Initial FDA registration and updates to registration;
✔ Main point of contact for FDA communication;
✔ Certificate of Registration issued by M.R. Global Expansion;
✔ Annual representation service;
✔ Regulatory support.

GET U.S. AGENT

Google Sites

Report abuse