FDA
US FDA compliance support, scoped honestly to what your product actually needs.
We help identify which US FDA requirements apply to your product category and support you in preparing the registration and documentation involved.
What is FDA?
The US Food and Drug Administration (FDA) regulates the import and sale of food, drugs, medical devices, cosmetics and certain other product categories in the United States. Depending on category, this can involve facility registration, product listing, labelling compliance, and in some cases pre-market approval or clearance pathways.
This is a US federal regulatory framework — Gurur Consultancy is not the FDA and does not certify FDA compliance or guarantee approval. Our role is to help Indian exporters understand which FDA requirements apply to their specific product category and support the registration, documentation and labelling preparation involved.
Because FDA requirements vary significantly by product type and change periodically, we recommend confirming category-specific requirements directly against current FDA guidance as part of any engagement, rather than relying on general information alone.
Why this matters for your business
Who typically needs FDA?
Applicability varies by business — here’s who this usually applies to.
- Food and beverage exporters targeting the US market
- Cosmetic product manufacturers exporting to the US
- Medical device or drug manufacturers assessing US regulatory pathways (these categories typically involve more complex, product-specific requirements)
Eligibility & requirements
- Relevant to any exporter whose product category falls under FDA-regulated categories for the US market
- Specific requirements — and whether pre-market approval is needed — depend heavily on product category; we help confirm this before proceeding
Documents & information
Commonly required documents may include:
How we take this forward
- 01
Category & Requirement Review
We help identify which FDA requirements apply to your specific product category.
- 02
Gap Assessment
Your current product, facility and labelling documentation is reviewed against those requirements.
- 03
Registration/Listing Preparation
We help prepare facility registration and product listing documentation, where applicable to your category.
- 04
Labelling Review
Product labelling is reviewed for compliance with applicable FDA labelling requirements.
- 05
Submission Support
We support you through the relevant registration or notification submission process.
Our approach to FDA
End-to-End Support
One partner from idea to registration to tender win.
Practical Guidance
Plain-language advice from people who have filed thousands of cases.
Documentation Support
Right documents, right format, right the first time.
Compliance-Focused Approach
We don't just register — we keep you compliant.
Government Procurement Expertise
We know GeM, CPP and tender portals inside-out.
Long-Term Business Support
We grow with you — from proprietorship to private limited.
Frequently asked questions
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Need Help With FDA?
Tell us your product category and US market plans, and we'll help identify which FDA requirements actually apply.