ソーシングゲートウェイ
Source Smart Launch Safe
K-Beauty One-Stop Solution
beauty
Delivering high-performance, climate-adaptive beauty solutions that prioritize skin-barrier repair and functional cosmetics to to match the shifting demands of modern self-care.
wellness
Guiding you toward holistic, longevity-focused wellness products that provides sensory relaxation and daily mental and physical stress relief, providing well-being as a necessity rather than a luxury.
food
Sensational, plant-forward functional foods that treat nutrition as preventative medicine while seamlessly aligning with modern preferences for upcycled sustainability and GLP-1 weight management support.
supplement
Find your next-generation, innovative supplements that focus on advanced cellular longevity and the gut-brain axis to deliver the science-backed results today's proactive consumers demand.
ソーシングゲートウェイ
With over a decade of FDA regulatory consulting experience, we have supported companies ranging from startups to billion-dollar enterprises. Our expertise spans the entire K-beauty supply chain—from product development and production to logistics and distribution—minimizing your risks of losing your precious K-beauty brand so you can focus on growing your business without worry. We are deeply integrated into the K-beauty supply chain, managing every step from sourcing to delivery and eliminating all the hassles for you as your K-beauty supplier. By sourcing directly from manufacturers and never through intermediaries, we guarantee that you receive only genuine products at the lowest possible cost, with zero risk of counterfeits.
We are an FDA regulatory consulting firm that completely removes compliance risks for U.S. brand owners. You can focus on your business while we handle all regulatory requirements—no worries, no surprises.
A Decade of FDA Regulatory Expertise
We source directly from manufacturers we have qualified ourselves—never through intermediaries. This ensures you receive only genuine products at the lowest possible cost, with zero risk of counterfeits from our supplies.
Directly Sourced Made-in Korea Products
We are deeply integrated into the entire K-beauty supply chain, managing every step from sourcing to distribution management as your K-beauty supplier. We eliminate all the hassles so you don’t have to.
One-stop Management and Transparency
Government recognition and strong industry partnerships reflect our proven credibility. Clients trust us for reliable, regulation-ready solutions that meet both public standards and business needs.
Korean Government Agencies Advisory and Panelist
ソーシングゲートウェイ
We offer comprehensive Compliance-to-Commerce service for beauty and health product businesses as your K-beauty supplier, including conducting production from FDA-compliant manufacturers, managing all FDA requirements such as device-specific premarket clearances--such as 510(k), De Novo--registrations, labeling compliance, handling importing and customs, and presenting your products at various tradeshows and exhibitions. Our expertise extends to coordinating logistics and ensuring your products meet the standards of major retailers like ULTA Beauty and Sephora, as well as online platforms like Amazon and Walmart. We also provide ongoing support for any FDA compliance issues during distribution.
Production Management
Manufacture and manage your K-beauty products from our FDA-compliant Korean manufacturers
FDA & State Compliance
Managing all FDA requirements: device-specific clearances, registrations, listings, labeling, U.S. Agent, Responsible Person, and so much more
Customs Solution
Handling importing and customs with expertise
Logistics and Delivery
Coordinating logistics, trucking, and doorstep delivery
Post-market Compliance
Ongoing support for any FDA compliance issues during distribution
Brand Ambassador
Expose your product in the U.S. market--both to your potential buyers and partners.
ソーシングゲートウェイ
Verified, FDA-compliant suppliers are utilized, and qualified professionals oversee coordination and operational processes. Activities related to product onboarding across retail and online platforms are managed as part of the overall process, while continuous compliance support is provided to ensure adherence to applicable FDA requirements.
01
Peace of mind with verified, FDA-compliant K-beauty supplies
02
End-to-end production to distribution from industry experts
03
Seamless onboarding to retail and online platforms
04
Ongoing compliance assistance as your business grows
ソーシングゲートウェイ
Starting by identifying the K-beauty products you envision, we take full responsibility for curating with qualified Korean manufacturers to produce and supply them, import these products into the U.S. market, and serve as your U.S. representative by undertaking all necessary tasks on your behalf. FDA compliance is consistently managed and monitored throughout the process, with ongoing oversight to ensure all regulatory requirements are maintained—allowing you to sit back, relax, and simply receive the best possible product.
Assessment
We begin by understanding your business goals, product requirements, and target market. Our team conducts a thorough assessment to identify your specific needs and tailor our services to ensure a seamless entry into the U.S. market.
Duration: 1 week
ソーシングゲートウェイ
Our FAQ section is designed to address the most common questions about our Compliance-to-Commerce Solution as your K-beauty supplier. Whether you're curious about our FDA compliance process, service offerings, or how we can help your business succeed in the U.S. market, you'll find clear and concise answers here. If you need further assistance, feel free to reach out through our contact link.
Q: How can we ensure the products we order are genuine? A: We guarantee the authenticity of our products by sourcing them directly from the manufacturers. We have conducted thorough audits of these manufacturers to ensure quality and reliability. This close relationship allows us to provide you with the right products at the best possible prices.
Q: Is my product Cosmetics or OTC product? A: Yes, we frequently receive that question. Rest assured, we are experts in FDA regulations. We can delve as deeply as necessary to ensure you understand what you're dealing with. Even better, you don't have to handle it yourself—we'll take care of it for you! Our service is designed to save you time and eliminate stress.
Q: I heard that distributing sunscreens in the U.S. market is tricky and complicated. How do you help? A: There are two sides to this issue. First, from the manufacturers' perspective, many are not compliant with the FDA's OTC drug regulations, which require a high level of GMP compliance. Achieving this is not an easy task. Second, from the perspective of U.S. brands, they also need to adhere to FDA regulations. The good news is that we handle both aspects. We inspect manufacturers and elevate their compliance to the necessary OTC drug level if they produce sunscreens. For brand owners, we manage the compliance process on their behalf. Thus, we address both sides of the problem effectively!
Q: Do you support onboarding to major retailers and online platforms? A: Absolutely. We ensure that your products meet all the requirements for ULTA Beauty, Sephora, Amazon, Walmart, and more. You may have heard of products being unexpectedly flagged or delisted. This often happens when they are non-compliant or fail to demonstrate and defend their regulatory standing. But don't worry—we handle all of that for our clients!
Q: What if compliance issues arise after launch? A: We offer continuous support for any compliance challenges, whether they arise from consumers, the FDA, or retailers. If consumers raise concerns about compliance, safety, or efficacy issues, we handle them efficiently. Should the FDA initiate an inquiry, we have the expertise to manage it effectively. While retailers may not be fully versed in FDA regulations, they are adept at identifying potential issues, and we ensure your defense is robust, keeping you ahead of the curve.
Q: I heard wellness products are very difficult. How do you help? A: We first assess the product and correctly identify what product category your wellness product falls under the FDA regulations. Is it a medical device? No worries. We will get your premarket clearance/approval, get the facilities registered, correctly implement necessary regulatory guardrails.
Q: I need to find a qualified medical device manufacturer to replace my current manufacturer. Can you help? A: Absolutely. Our consultants qualify Korean manufacturers under FDA's CFR 820 Quality Management System Regulations. So, you can be rest assured that you are working with the right manufacturers.
Q: My container is stuck at the border. Can you help? A. Definitely. We reach out to customs and FDA officers as your official correspondent and get the goods released.