
Manage your FDA Prior Notices with a monthly compliance plan
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What you get with this Offer
Under U.S. regulations, Prior Notice submission is mandatory for every shipment entering the U.S. This service ensures your submissions are handled accurately, consistently, and on time, reducing the risk of delays, detentions, or refusals.
This service is offered through three monthly plans:
BASIC – $410/month
Ideal for exporters with low but regular shipment frequency.
- Up to 3 FDA Prior Notices per month
- Up to 12 SKUs per submission
- FDA Product Code creation and validation
- Correction of inconsistencies and regulatory errors
- Basic compliance review of product descriptions
STANDARD – $780/month
For exporters with moderate shipment volume and broader product lines.
- Up to 6 FDA Prior Notices per month
- Up to 15 SKUs per submission
- Comprehensive compliance review for each submission
- Ingredient risk screening
- Consistency checks across submissions
- Pre-submission corrections to reduce FDA flags
- Ongoing email or WhatsApp support
ADVANCED – $1,150/month
For high-volume exporters requiring speed and maximum regulatory control.
- Up to 10 FDA Prior Notices per month
- Up to 20 SKUs per submission
- Advanced compliance and formulation risk review
- Historical consistency analysis across submissions
- Priority handling for urgent shipments
- FDA detention risk prevention review
- Ongoing email or WhatsApp support
Each Prior Notice is typically submitted within 1 business day after receiving complete and accurate information.
Important notes:
- This is a monthly subscription service
- Covers one company account
- Additional Prior Notices may be added separately
- Submission does not guarantee FDA clearance
- Final decisions are made by FDA and U.S. Customs authorities
Get more with Offer Add-ons
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I can upgrade your plan to Standard (up to 6 Prior Notices/month)
Additional 5 working days
+$370 -
I can upgrade your plan to Advanced (up to 10 Prior Notices/month)
Additional 5 working days
+$740
What the Freelancer needs to start the work
1. Manufacturer: name, full address (street, city, state/province, country, ZIP), FDA registration number (required), DUNS number
2. Importer: name, full address, FDA registration number (if available), DUNS number (if available)
3. Ultimate Consignee: name, full address, FDA registration number (if available)
4. Shipper/Exporter: name and full address
5. Product details: product name, FDA product code (if available), full description, form (solid, liquid, capsule, powder, etc.), packaging type, net quantity per unit, lot/batch number, country of origin, quantity per case, quantity per pallet (if applicable)
6. Transport details: Air Waybill (AWB), mode of transport, carrier/airline, flight number, estimated arrival date and time, U.S. port of entry (FDA/CBP)
All information must be complete and accurate to ensure timely submission and avoid delays.