Why the U.S. Market?

The earlier you start, the better. FDA processes take time and there's no way to shortcut them, but if you start at the right point, you can be in the U.S. market on schedule without delays. Recommended lead times by category: Cosmetics: At least 2-3 months ahead Dietary Supplements: At least 4-6 months ahead (if your product contains a new ingredient, FDA notification and a mandatory 75-day wait are required) OTC Drugs: At least 6-12 months ahead Medical Devices: Depends on the device's risk class; can range from 6 months to 3 years This holds even if your product is already manufactured and on the market. Registration, label adaptation, and required notifications still take time. So the moment you decide to target the U.S., that's the moment to reach out to us. The earlier we start, the smoother we can get you into the market.

Yes. We can operate as an extension of your international leadership team, help establish the commercial model, coordinate specialist partners and provide clear oversight of US operations.

Our model connects market assessment, launch readiness, channel and sales operations, partner coordination and ongoing performance management.

Absolutely. We can coordinate your agencies, distributors and specialist service providers so every workflow follows one strategy and reporting rhythm.

Short answer: no, none of these. Here's why it matters for you. FDA does not approve cosmetics or most dietary supplements before they go to market, there's no premarket approval process for these categories. So "FDA approved" simply isn't accurate, and using it puts your labeling at legal risk. "FDA registered" may be technically true if your facility registration is complete, but if it's used in a way that implies FDA endorsement, it still creates a problem. Registration is an administrative notification, not proof that your product is safe. The official FDA logo can never be used under any circumstances, it's a federal emblem, and unauthorized use is a separate violation on its own. We review your labels and marketing materials for exactly this kind of language, and help you communicate compliance in a way that's both accurate and reassuring to customers.

The process runs through seven steps: product classification, designating a responsible person, facility registration and product listing, ingredient screening, label adaptation, a safety substantiation file, and customs/logistics planning. Done in the right order and completed fully, these steps keep your entry smooth and predictable. Cost depends on how many products you have, how far your current label is from U.S. requirements, and whether your formulation needs any changes. Because of that, we need to look at your specific products and current status before giving you a realistic figure. When you reach out, we review your product in our first conversation and come back with a clear roadmap and a price quote tailored to you.

This depends on the arrangement we make with your brand, and it can work in three ways: We take on distribution for your brand ourselves, Distribution stays with you, and we run the process on your behalf for a fee, Or you choose to handle it entirely on your own. We work with you to decide which model fits, based on your product category, sales goals, and how much operational control you want to keep. We walk through these options together in our first conversation.

Yes. We have warehouses in New Jersey, close to the port. Once your products arrive at our warehouse, we handle sales and distribution directly from there. That means your product moves straight from customs into operation, no need to find a separate warehousing or logistics partner.