FDA Compliance Made Simple for the U.S. Market
Entering the U.S. market requires businesses to understand product-specific FDA requirements, facility obligations, labeling standards, import procedures, and ongoing regulatory responsibilities. We help businesses navigate these requirements with practical guidance — from product classification and documentation to import compliance and ongoing regulatory support.
Identify the Product & FDA Category
Determine how the product is classified under U.S. regulations, such as food, dietary supplement, cosmetic, drug, medical device, or other regulated product.
Review FDA Regulatory Requirements
Identify the regulations applicable to the product, including ingredients, manufacturing, safety, labeling, claims, packaging, and import requirements.
Verify Ingredients & Formula
Review each ingredient for FDA compliance, permitted use, applicable limits, and requirements such as GRAS status or New Dietary Ingredient (NDI) considerations for dietary supplements.
Establish Manufacturing Compliance
Ensure the manufacturing facility follows applicable FDA Good Manufacturing Practices (GMPs) and maintains appropriate quality and safety systems.
Facility Registration
Complete the applicable FDA facility registration requirements. For example, food facilities generally require FDA Food Facility Registration, while other product categories may have different registration requirements.
Obtain Required FDA Numbers / Identifiers
Where applicable, obtain or verify identifiers such as FDA registration details, FEI number, DUNS/unique facility identifiers, or product-specific registration/listing information.
Product Testing & Safety Documentation
Prepare appropriate laboratory testing, specifications, Certificates of Analysis (COAs), stability information, contaminant testing, and safety documentation based on the product category.
FDA-Compliant Label Review
Review the complete label for required declarations, including product identity, net quantity, ingredients, nutrition/supplement facts, allergen declarations, manufacturer/distributor information, warnings, and FDA-specific requirements applicable to the product.
Review Marketing & Health Claims
Evaluate website content, Amazon listings, advertisements, brochures, social media, and packaging claims to ensure they do not create prohibited or misleading claims. For dietary supplements, carefully distinguish permissible structure/function claims from disease claims.
Prepare Import Documentation
Ensure commercial invoices, packing lists, shipping documents, product information, FDA registration details, and other required documentation are consistent and accurate.
FDA Prior Notice / Import Entry Compliance
Where applicable, complete required Prior Notice and ensure the shipment information is correctly submitted through the appropriate U.S. import process.
U.S. Customs & FDA Import Review
The shipment may be reviewed by FDA and U.S. Customs and Border Protection (CBP). FDA may examine documentation, inspect shipments, or collect samples where appropriate.
Respond to FDA Queries or Detentions
If FDA identifies an issue, promptly provide clarification, supporting documents, corrective actions, or other information required to resolve the matter.
Maintain Post-Market Compliance
Continue monitoring product quality, complaints, adverse events where applicable, labeling, claims, manufacturing controls, and regulatory changes after entering the U.S. market.
Renew & Maintain Ongoing Compliance
Track applicable registration renewals, facility information updates, certifications, testing, records, and regulatory changes to keep the product continuously compliant.
Practical Support for FDA Compliance
We help businesses understand and manage key FDA requirements, including regulatory assessment, facility registration, labeling, claims, import documentation, and ongoing compliance.
FDA Regulatory Assessment
Product category, applicable FDA requirements, and market-entry obligations ka initial assessment.
Facility Registration Support
Applicable facility registration requirements ko understand aur complete karne mein support.
Label & Claims Review
Product labels, website content, marketplace listings, and marketing claims ka compliance-focused review.
Import & Ongoing Compliance
Prior Notice, import documentation, FDA/CBP review, and ongoing compliance requirements mein support.
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Ready to Enter the U.S. Market with Confidence?
Tell us about your product, manufacturing setup, and U.S. market plans. Our team can help you understand the applicable FDA compliance requirements and next steps.