FDA/USFDA Registration
To legally export food, dietary supplements, cosmetics, or medical devices to the United States, your facility must be registered with the US FDA, and you must have a US Agent (a person or company based in America who receives FDA communications on your behalf). Shipments from unregistered facilities are detained at US customs. We handle the full FDA registration, provide the mandatory US Agent service, review your product labels for compliance, and assist with any import alerts.
We Take Care of Everything
From preparing your documents to training your team and supporting you during the final audit, we handle the entire process. You focus on running your business, we make sure you get certified.
Who Needs This?
This certification is commonly needed by businesses in these industries:
Food & Supplement Exporters to USA
Medical Device Manufacturers
Pharmaceutical Exporters to North America
Cosmetics Brands
Ayurvedic & Herbal Exporters to US
Surgical Equipment Exporters
Dietary Supplement Brands
Canned Food Exporters
What You Gain From This Certification
Here is how this certification helps your business grow and win more clients:
We register your facility in the official FDA database
We provide the mandatory US Agent service for Indian exporters
Label review to make sure your packaging meets US requirements
Help with customs holds, import alerts, and registration renewals
Documents You Will Need
Get these documents ready before we start. We will review them and help you with anything that is missing.
Product Technical Data Sheet & Drawings
Existing Product Test Reports (if any)
Raw Materials Certificate of Analysis (COA) / Specifications
Manufacturing Process Flowchart & Plant Layout Map
Product User Guides or Safety Instruction Leaflets
How We Get You Certified: Step-by-Step
Here is exactly what happens from the day you contact us to the day you get your certificate:
Standard Identification
We evaluate your product's design and features to determine the exact compliance directives and standards needed.
Sample Testing & Coordination
We coordinate sample submission to accredited labs and track testing reports to ensure your product meets target limits.
Technical File Preparation
We compile all lab test reports, user manuals, declarations of conformity, and drawings into a complete Technical File.
Factory Production Audit
We check and optimize your factory production line controls to satisfy standard requirements.
Marking & Certification
Receive the official test certifications and approval to apply compliance labels (like CE/RoHS) to your products.
How Long Does It Take?
Here is how long it usually takes from when we start to when you get your certificate:
Average Completion Time
15 to 25 Working Days (Depends heavily on target laboratory queue times and specific safety testing cycles)
Why Businesses Choose Us
Here is what you can expect when you work with us:
Dedicated Audit Support
We stand with you through every step until your certificate, license, or audit report is fully approved.
Experienced Lead Auditors
Our consultants are seasoned audit specialists with over 6 years of hands-on certification experience.
No Hidden Costs
We quote flat, all-inclusive fees covering setup, consultation, coordination, and final approvals.
End-to-End Handholding
We do not just tell you what to do; we write the documents, train your staff, and handle the inspectors.
Lifetime Advisory Support
Get continuous assistance for annual surveillance audits, compliance renewals, and standard updates.
Common Questions
Answers to the questions we hear most often about this certification:
Any Indian manufacturer, processor, or packer of food, dietary supplements, cosmetics, or medical devices that will be sold in the US market. If your goods are held at a US port because of registration issues, that is fixable; contact us.
Yes. If your factory is outside the US, you must have a US-based contact person (US Agent). We provide this service as part of your registration.
For most international certifications like CE and RoHS, yes: your product needs to be tested at an approved lab. We arrange the testing and handle all the paperwork for you.
Yes, if you change your product design or materials without informing the certification body, your certificate can be suspended. We help you manage any product changes properly so this does not happen.
Related Standards
Other certifications and compliance standards commonly required in your sector:
Guides & Resources
Read our plain-English guides to understand more about compliance and certification: