You Focus on Success,
We’ll Focus on Compliance
Licensing can be one of the toughest hurdles for small and start-up businesses—especially FDA LTOs, product notifications, and registrations. These require expertise in FDA rules, GMP compliance, and industry regulations. We handle the paperwork and processes so you can focus on growing your business.
"Derigin has been incredibly helpful in navigating the challenging path of starting a business. Not only do they manufacture products for my brand, but they also assisted me with obtaining FDA licenses. Now, I have more time to focus on growing my business without the stress of regulatory issues."
FDA LICENSING ASSISTANCE
As our client, you get more than just manufacturing—we offer a value-added, one-stop-shop service so you don’t have to stress over tedious regulatory requirements. We’re a licensed FDA manufacturer with years of expertise in skincare, cosmetics, and food regulations. Depending on our manufacturing agreement, we can even provide your FDA License to Operate (LTO) free of charge, along with assistance in securing your Certificate of Product Notification (CPN) and Certificate of Product Registration (CPR)—fast, smooth, and stress-free.
Think of us as your behind-the-scenes compliance partner. While you focus on selling, scaling, and succeeding, we take care of the complex paperwork, submissions, and follow-ups to ensure your products meet every FDA requirement without delays. With us, you save time, avoid headaches, and gain peace of mind knowing your business is in expert hands.
FDA LTO
In the Philippines, your FDA License to Operate (LTO) is issued according to the type of products you sell or trade. A specific FDA center regulates each product category:
- Skincare & Cosmetics: Apply under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR).
- Nutraceuticals & Food Products: Apply under the Center for Food Regulation and Research (CFRR).
Choosing the correct category ensures your business complies with the right regulations, avoids delays, and operates legally.
After Your FDA LTO – What’s Next?
Getting your FDA License to Operate (LTO) is like unlocking the door—you’re now officially allowed to operate. But before your products can hit the shelves, there’s another important step: product registration.
Here’s how it works:
Only a licensed manufacturer can register products with the FDA. That’s where we come in. Because we’re already a licensed FDA manufacturer, we can help you secure:
- Certificate of Product Notification (CPN) for each skincare or cosmetic product.
- Certificate of Product Registration (CPR) for each nutraceutical or food product.
And yes every product and every variant (like different scents, flavors, or sizes) needs its own CPN or CPR.
The process can be tedious and technical, but with us handling the paperwork, you can simply focus on selling your products, growing your business, and serving your customers. We’ll take care of the rest.