Submissions & Registrations
Compliance
​
Don’t Let Regulatory Submissions Hold You Back
Bringing a product to market isn’t just about great formulation and branding. If you don’t handle FDA submissions, product registrations, and compliance filings correctly, you risk delays, fines, and even recalls. Regulatory mistakes can hurt your reputation, sales, and growth—all of which can be avoided with the right help.
At AMSRA Consulting, we make regulatory filings simple. We handle FDA facility registrations, NDI submissions, label compliance, and everything in between—ensuring your products are ready to launch quickly and legally compliant.
​​​
We Make Submissions Simple
We know you don’t have time to waste on regulatory paperwork. You need a partner who gets things done right and helps you move quickly. That’s where we come in, because
Missing Submissions lead to FDA Warnings and Delays
Regulatory Complexity Is Overwhelming
Retail and Amazon Compliance Requirements is Daunting
We ensure your product labels meet FDA standards, product listings are fully compliant, and marketplace requirements like Amazon’s are handled. This way, your products are ready to sell—and compliant across all channels.
Areas of Service
With over a decade of experience, we take the guesswork out of compliance by providing expert guidance and tailored services.
FDA Facility Registration & Renewal
-
FDA Registration (21 CFR 1) for domestic & foreign supplement manufacturers
-
Biennial registration renewals & updates
-
U.S. Agent services for foreign firms
Dietary Supplement Notifications & Submissions
-
New Dietary Ingredient (NDI) Notifications (21 CFR 190)
-
GRAS (Generally Recognized as Safe) Self-Determinations & Submissions
-
Structure/Function claim notification filings
-
Serious Adverse Event Reporting for dietary supplements and cosmetics
Label Compliance & Product Listings
-
FDA-compliant Supplement Facts panel & ingredient declarations
-
Product listing under the Dietary Supplement and Nonprescription Drug Consumer Protection Act and MOCRA
-
Assistance with Amazon & retailer compliance requirements
-
FDA Facility Registration & Renewal
We manage your FDA Facility Registration for both domestic and foreign manufacturers. We also handle biennial renewals, making sure your facility is always up-to-date and audit-ready. -
NDI Notifications & Submissions
If your product contains a New Dietary Ingredient, we ensure that your NDI Notification is filed in compliance with 21 CFR 190. We also handle GRAS self-determinations and Structure/Function claim filings to keep your claims compliant. -
Serious Adverse Event Reporting
For dietary supplements and cosmetics, we handle adverse event reporting to ensure your company stays on top of any consumer reports. We manage the entire reporting process, giving you peace of mind and avoiding potential legal risks. -
Label Compliance & Product Listings
We ensure your product labels are FDA-compliant and help with product listings for retail and online platforms like Amazon. We take the guesswork out of regulatory requirements, so you can focus on sales.
Why Choose AMSRA Consulting for Your Submissions & Registrations?
Experience That Matters
With over 10 years of industry experience, AMSRA Consulting has helped businesses just like yours navigate complex regulatory filings
Comprehensive Service
From NDI notifications to serious adverse event reporting, we handle all your regulatory needs under one roof, giving you peace of mind.
