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Business Introduction
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Business Introduction

Complex regulatory processes?
That’s why we’re here.

SC Holdings provides a comprehensive one-stop solution for K-brands entering global markets. We support the full process for the United States and Canada, including regulatory registration, compliance-related submissions, and labeling that meets local regulatory requirements.

Launched in January 2025, our FDA (U.S.) and Health Canada (Canada) regulatory registration and labeling support services have expanded rapidly, assisting a growing number of K-brands in entering the North American market. SC Holdings will continue to strengthen its capabilities to support more brands in achieving stable and successful market entry.

Regulatory & Labeling Process

 

  • STEP 1

    Consultation & Document Review

    We provide guidance on the required registration or notification types, necessary documents, timelines, and costs in a clear and straightforward manner.

  • STEP 2

    Regulatory Registration & Approval Process

    We handle regulatory registration and approval procedures in accordance with each country’s requirements, including FDA registration and CN issuance.

  • STEP 3

    Compliance Label Development

    We develop product labels and modify packaging artwork in accordance with local regulatory and language requirements.

  • STEP 4

    Final Delivery & Completion

    We deliver the finalized regulatory information and compliant label files upon completion of the process.

  • U.S. FDA Registration Support

    To sell products in the United States, compliance with FDA requirements is necessary depending on product type.
    General cosmetic products require Cosmetic Product Listing, while OTC drug products must comply with applicable OTC monograph or drug registration requirements.

  • Health Canada Registration Support

    In Canada, cosmetic products must be notified through a Responsible Person (RP) based system. Depending on product classification, either Cosmetic Notification (CN) or Natural Health Product (NHP) registration is required. SC Holdings provides full-service support throughout these processes.

  • Multilingual Label Compliance & Production

    We provide a one-stop service covering label content development, regulatory compliance review, translation, and label production. All labels are prepared in accordance with requirements from regulatory authorities such as the FDA and Health Canada.

Country Registration Costs & Lead Time

Country Regulatory Body Target Products Types of Registration / Notification Types Cost / Product
(excl. VAT)		 Lead Time Annual
Renewal Required		 Annual
Renewal Fee
United
States		 FDA General moisturizing cosmetics Cosmetic Product Listing Sticker label ₩350,000 15 business days Recommended ₩200,000
General moisturizing cosmetics Cosmetic Product Listing Label compliance consulting ₩550,000 20 business days Recommended ₩200,000
OTC Drug (Over-the-counter Drug) OTC Sticker label ₩700,000 10~20 business days Required ₩500,000
General food products Label Review & Regulatory Compliance Sticker label ₩190,000 7 business days Not applicable  
Functional food, health supplements Label Review & Regulatory Compliance Label compliance consulting ₩290,000 10 business days Not applicable  
Canada Health
Canada		 General moisturizing cosmetics Cosmetic Notification Label compliance consulting ₩495,000 30 business days Not applicable  
Natural Health Products NHP (Natural Health Product) Label compliance consulting ₩925,000 90 business days  
General food products Label Review & Regulatory Compliance Sticker label ₩300,000 5 business days  
Functional food, health supplements NHP (Natural Health Product) Label compliance consulting ₩800,000 90 business days  

※ U.S. (OTC): Products such as sunscreens and acne treatment products are classified and regulated as OTC (Over-The-Counter) drugs, which can be sold without a prescription.
※ Canada (NHP): Similar or equivalent functional products are classified and regulated under the Natural Health Product (NHP) framework.

※ After completion of dieline (artwork layout), if additional sticker label production is requested, an additional fee of KRW 100,000 per SKU will apply, with an estimated processing time of approximately 7 business days.
※ For food products, additional costs and extended processing time may apply depending on the number of ingredients and raw material composition.
※ Processing time is calculated based on the date when all required materials are submitted. Additional information requests may occur during the process.

 
Country Target Products Notes
United States
(FDA)		 General Food, Functional Food, Health Supplements
Under U.S. FDA regulations, conventional foods do not require a separate pre-market approval process; however, they must comply with mandatory FDA food labeling requirements.Product name, net quantity, Nutrition Facts panel, ingredient list, allergen information, and manufacturer details must be presented in accordance with FDA formatting standards and specified typography requirements. Non-compliance with these requirements may result in restrictions on sales within the United States.
SC Holdings provides support for label design and review reflecting FDA food labeling requirements, helping facilitate a more stable entry into the U.S. market.
Canada
(Health Canada)		 General Food, Functional Food, Health Supplements
Under Canadian regulations, conventional foods do not require a pre-market approval process; however, they must comply with mandatory bilingual labeling requirements in English and French. Product name, net quantity, Nutrition Facts Table, ingredient list, allergen information, and manufacturer details must be accurately displayed in accordance with the Canadian Food and Drug Regulations (FDR), including prescribed formatting and font size requirements. Non-compliance may result in restrictions on distribution within Canada. SC Holdings provides support for English and French label development and review in line with Health Canada requirements, helping ensure a more stable entry into the Canadian market. In addition, functional foods and Natural Health Products (NHPs) require an NPN (Natural Product Number) prior to sale. SC Holdings also supports NHP licensing and labeling compliance throughout the registration process.
 

Other Services

Service Type Description Cost (excl. VAT) Lead Time Annual
Renewal Required
Cosmetic Manufacturing Facility FDA Registration FDA registration of manufacturing facility and FEI issuance ₩1,000,000 Approx. 30 business days Required
Food Manufacturing Facility FDA Registration FDA registration of food manufacturing facility and FEI issuance ₩1,500,000 Approx. 90 business days Required
Canada Manufacturing Facility FSRN Registration Issuance of FSRN for food manufacturing facility ₩3,000,000 Approx. 90 business days Required
DUNS Number Issuance Agency service for obtaining D-U-N-S required for FDA registration ₩100,000 Approx. 7 business days (up to 30 days) Not required
Label Content Review Label text review service ₩150,000 Approx. 5~10 business days Not required
Labeling Service Sticker labeling work service ₩200,000 Approx. 5~10 business days Not required
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