Amazon FDA Registration doesn’t have to be overwhelming. Our service helps brands in the dietary supplements, cosmetics, and health product categories achieve full compliance with ease. From FDA registrations and product label reviews to preparing documentation for Amazon marketplace approval — every step is handled with precision.
With a deep understanding of Amazon FDA requirements, we ensure your product is ready to launch, remain compliant, and scale confidently — without delays or regulatory setbacks.
Simplify FDA Rules. Protect Your Brand.
Ensure your facility and products are properly listed and registered with FDA, covering dietary supplements, cosmetics, and other regulated goods.
Design fully compliant labels with the correct ingredient declarations, warnings, and formatting that meet FDA and Amazon marketplace standards.
Avoid regulatory risks. We analyze your ingredients, claims, and intended use to determine if your product qualifies as a supplement, cosmetic, or drug.
Get complete backend documents ready—Certificates of Analysis (COA), SDS, GMP certifications—to meet FDA, Amazon, and category-specific listing requirements.
Navigate FDA rules confidently. Our experts help with NDI Notifications, structure-function claims, VCRP filings, adverse event reporting systems, and more.
Prepare category-specific compliance packages and optimize your listings for safe and approved selling — avoiding restricted claims and banned ingredients.
Captens effectively turned around a struggling home improvement brand using a smart, innovative, and practical variation launch strategy.
A seasonal apparel brand aimed to reach a sales target of $100,000 per month…
Captens was approached by a prominent grocery and snack brand to help launch their new products on Amazon.
We analyze FDA guidelines, Amazon policies, and product classifications to identify exactly what documents, certifications, and compliance actions are needed.
We review your product formulas, ingredients, labels, and certificates—then build a complete compliance file ready for FDA, Amazon, and marketplace approvals.
We draft, file, and manage your FDA listings, facility registrations, claims compliance, and Amazon listing optimization—keeping your brand protected and positioned for growth.
Getting FDA compliant on Amazon isn’t just about paperwork — it’s about selling with confidence.
An expert Amazon FDA registration agency helps you navigate complex regulations, secure necessary approvals, and ensure your product listings meet all compliance standards. From FDA submissions and label reviews to Amazon documentation and approval processes, every step is managed with precision. This means faster launches, fewer risks, and listings that not only meet Amazon’s requirements but also build trust with shoppers.
We proactively address FDA, Amazon, and marketplace standards to keep your products fully compliant.
By streamlining FDA filings and documentation, we help you launch faster and reduce costly delays.
We identify regulatory gaps early, helping you avoid fines, rejections, and expensive reformulations.
A fully compliant product boosts consumer confidence and strengthens your market authority.
We manage your FDA submissions, listing approvals, and ongoing compliance tasks so you stay focused on scaling.
From U.S. FDA to Amazon marketplace standards, we craft a compliance strategy that scales globally.
” Their team transformed our product listings with stunning visuals and optimized descriptions, leading to a noticeable increase in our sales within just a few weeks. The attention to detail and deep understanding of Amazon’s algorithm made all the difference. Highly recommend!”
E-commerce Entrepreneur
” Their team transformed our product listings with stunning visuals and optimized descriptions, leading to a noticeable increase in our sales within just a few weeks. The attention to detail and deep understanding of Amazon’s algorithm made all the difference. Highly recommend!”
E-commerce Entrepreneur
” Their team transformed our product listings with stunning visuals and optimized descriptions, leading to a noticeable increase in our sales within just a few weeks. The attention to detail and deep understanding of Amazon’s algorithm made all the difference. Highly recommend!”
E-commerce Entrepreneur
” Their team transformed our product listings with stunning visuals and optimized descriptions, leading to a noticeable increase in our sales within just a few weeks. The attention to detail and deep understanding of Amazon’s algorithm made all the difference. Highly recommend!”
E-commerce Entrepreneur
We assist with dietary supplements, cosmetics, medical devices, and select OTC products.
Yes, we offer full support—from facility registration and product listing to compliance audits and documentation.
Absolutely. We prepare category-specific documentation, SDS files, and COAs to meet Amazon’s standards.
We conduct a full ingredient review and advise on reformulations or alternative compliance strategies if needed.
Yes, we help with FDA inspection readiness, conduct mock audits, and assist in drafting responses to 483 observations.
Yes, our team includes FDA regulatory specialists and licensed professionals for strategic compliance support.
Timelines vary based on product type, but basic listings typically take 2–4 weeks once all documents are ready.
Yes, we assist with remediation plans, corrective action drafting, and communication with the FDA.
Yes! We offer complete Amazon launch services, including listing creation, keyword optimization, and marketing strategies.
We’ve got you covered — from brand identity design (logos, packaging) to compliance, launch, and growth support.
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