BESCHAFFUNGS-GATEWAY
BESCHAFFUNGS-GATEWAY
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 supply chain—from product development and production to logistics and distribution—minimizing your compliance risks 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. 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.
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. 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
BESCHAFFUNGS-GATEWAY
We offer comprehensive Compliance-to-Commerce service for beauty product businesses, including conducting production from FDA-compliant manufacturers, managing all FDA requirements such as registrations and labeling, handling importing and customs, and managing online and offline sales accounts. 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
Manufacture your K-beauty products from our FDA-compliant Korean manufacturers
FDA Compliance
Managing all FDA requirements: registrations, listings, labeling, U.S. Agent, Responsible Person, and more
Import and Customs
Handling importing and customs with expertise
Logistics and Delivery
Coordinating logistics, trucking, and doorstep delivery
Sales Management
Overseeing your sales account of major retailers (i.e. ULTA Beauty, Sephora) and online platforms (i.e. Amazon, Walmart)
Post-market Compliance
Ongoing support for any FDA compliance issues during distribution
BESCHAFFUNGS-GATEWAY
Verified, FDA-compliant suppliers offer peace of mind, while industry experts provide comprehensive sales account management and support. The onboarding process to both retail and online platforms is seamless, and continuous compliance assistance supports your business growth.
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Peace of mind with verified, FDA-compliant suppliers
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End-to-end production to distribution from industry experts
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Seamless onboarding to retail and online platforms
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Ongoing compliance assistance as your business grows
BESCHAFFUNGS-GATEWAY
Starting by identifying the K-beauty products you envision, we collaborate with our qualified Korean manufacturers to produce them. We then import these products into the U.S. market and handle their sales for you. FDA compliance is consistently managed and monitored. You will receive regular sales reports detailing your performance, ultimately leading to onboarding with major U.S. retailers.
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
BESCHAFFUNGS-GATEWAY
Our FAQ section is designed to address the most common questions about our Compliance-to-Service. 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.
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