You will get FDA PRIOR NOTICE SUBMISSION
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Project details
I provide accurate and fast FDA Prior Notice submissions for shipments of food, beverages, dietary supplements and animal feed entering the United States. Prior Notice is required for every shipment and must be filed before arrival in the US, according to FDA timing rules. Incorrect or missing filings may result in delays, holds or refusal of entry.
The price of this project applies to one Prior Notice submission, meaning one shipment. You may include multiple products in the same Prior Notice as long as all items are shipped under the same Air Waybill. If you have multiple shipments, each one requires a separate Prior Notice and a separate project.
To prepare the filing, you must provide:
• FDA registration number, name and full address of the importer, manufacturer, and receiver/storage facility.
• Product details: description, composition, barcode, batch/lot numbers and traceability codes.
• Packaging details: unit size (e.g., 20 ml, 100 g), packaging material/type.
• Case details: units per case and total cases (products must not be mixed in the same case).
• Shipment details: logistics company, airline/carrier, arrival date/time and US port of entry.
• Air Waybill.
The price of this project applies to one Prior Notice submission, meaning one shipment. You may include multiple products in the same Prior Notice as long as all items are shipped under the same Air Waybill. If you have multiple shipments, each one requires a separate Prior Notice and a separate project.
To prepare the filing, you must provide:
• FDA registration number, name and full address of the importer, manufacturer, and receiver/storage facility.
• Product details: description, composition, barcode, batch/lot numbers and traceability codes.
• Packaging details: unit size (e.g., 20 ml, 100 g), packaging material/type.
• Case details: units per case and total cases (products must not be mixed in the same case).
• Shipment details: logistics company, airline/carrier, arrival date/time and US port of entry.
• Air Waybill.
Industry
Ecommerce, Food & Beverage, Logistics & Supply Chain Management, Manufacturing & Storage, Retail & WholesaleWhat's included $170
These options are included with the project scope.
$170
- Delivery Time 4 days
Optional add-ons
You can add these on the next page.
Fast 1 Day Delivery
+$80Frequently asked questions
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AG
Anastasiia G.
Jun 30, 2026
US Compliance review for skincare label
Marcela was diligent, professional, and highly responsible throughout the entire compliance process. She consistently delivered everything she promised on time, communicated clearly, and was thorough in her work. I appreciated her reliability and attention to detail, which made the process smooth and efficient. I would not hesitate to work with her again and would gladly hire her for future compliance needs.
JW
Josh W.
Jun 26, 2026
Bottle Label Conforming/Compliance Check
SL
Salo L.
Jun 25, 2026
FDA Compliance Review Request
She is very helpful, professional and I would definitely hire her for my future cosmetic works.
LH
LM H.
Jun 17, 2026
WERCS DATA INPUT
TS
Tom S.
Jun 10, 2026
MoCRA Compliance Consultant Needed
Marcela helped greatly to bring our cosmetic packaging and product labels into compliance with MoCRA guidelines!
About Marcela
Head of Regulatory Compliance
100%
Job Success
Miami, United States - 2:33 am local time
My expertise covers the main global regulatory agencies for food, dietary supplements, cosmetics, textiles, medical devices, electronics, and various consumer products.
My services include:
- UNITED STATES - (FDA, USDA, EPA, FCC, CPSC, CBP, FWS):
✅ FDA Facility Registration:
Food, dietary supplements, cosmetics, OTC-adjacent products, and pet food facilities.
Foreign + domestic registrations, renewals, product listings, and U.S. compliance adaptation.
✅ US Agent Services:
Acting as your official U.S. Agent to represent your company before FDA and U.S. authorities.
✅ FSVP Agent Services:
Foreign Supplier Verification Program development for food and supplement importers.
✅ EPA Registration:
Pesticides, disinfectants, industrial/automotive chemicals.
✅ FCC Certification:
Wireless products, Bluetooth devices, smart electronics.
✅ USDA Licensing & Inspection Support:
Animal-based, agricultural, and honey/propolis products.
✅ FWS Import Permits (CITES):
Exotic leathers, wildlife-derived materials, hunting trophies.
✅ CPSC Compliance:
Children’s products, toys, textiles, law labels, safety testing requirements.
✅ CBP Customs Compliance:
HTS classification, import documentation, Prior Notice, and customs support.
- EU & UK Compliance:
I support companies entering the European Union and UK markets, including:
✅ EU Responsible Person (RP) Guidance & Setup:
Cosmetics, supplements, electronics, textiles, and various consumer products.
✅ EU/UK Labeling Compliance:
Adaptation for multilingual labeling (EN/FR/DE/ES/IT), technical file requirements, claims, allergens, nutrition panels, textile labeling and fiber composition.
✅ Product Compliance & Registration:
– EU Food & Supplement rules (EFSA)
– Cosmetic Product Notification Portal (CPNP)
– UK SCPN Notification
– CE/UKCA pathways
– Textile & apparel compliance (fiber rules, care labels, REACH)
✅ Documentation & Market Access:
GMP expectations, safety assessments, product information files (PIF), and import documentation.
- LATIN AMERICA (Brazil, Mexico, Chile, Colombia):
Support for brands expanding across Latin America:
✅ Brazil (MAPA / ANVISA guidance):
Food, supplements, cosmetics, packaged foods.
✅ Mexico (COFEPRIS / RFC Importer Registration):
Food, cosmetics, dietary supplements, OTC-adjacent products.
✅ Regional Labeling Compliance:
Adaptation for Spanish/Portuguese labeling, mandatory warnings, nutritional tables, allergen formats.
- GLOBAL SERVICES:
Regardless of your target market:
🎯 Labeling Compliance & Regulatory Adaptation
FDA + EU + UK + LATAM-compliant labels, packaging, claims, and disclosures.
📄 Safety Data Sheets (SDS)
SDS preparation following OSHA HazCom 2012 / GHS.
🧩 HTS Classification & Market Feasibility
Identifying regulatory requirements before exporting.
Working Policy:
All regulatory reports include a 10-business-day clarification window from the date of delivery. After this period, any additional review, follow-up, or new questions will be handled as a separate consulting engagement.
Work begins only after all requested product information and documentation have been fully and accurately provided by the client.
Final responsibility for verifying technical product data (including ingredient quantities, specifications, claims, and label details) remains with the client prior to commercialization.
Steps for completing your project
After purchasing the project, send requirements so Marcela can start the project.
Delivery time starts when Marcela receives requirements from you.
Marcela works on your project following the steps below.
Revisions may occur after the delivery date.
Shipment Data Collection
Provide product details, manufacturer info, shipper/consignee, carrier, packaging, quantity, and all shipment data needed to prepare your FDA Prior Notice.
FDA Prior Notice Submission
I will complete your FDA Prior Notice and send the official confirmation number and PDF summary required for customs clearance.