The FDA is a maze and it’s easy to quickly feel overwhelmed. You need to register, not master the maze. Luckily, I have successfully guided clients from around the world through it.
Don’t get frustrated, get FDA registered.
It can be confusing to know what system to use —CDER Direct, Cosmetics Direct, FURLS—or make heads or tails out of all the acronyms, UFI, UNII, NDC, to name a few.
And it’s important not to waste time or waste money paying FDA fees that may not be required.
For the past 15-years I have worked exclusively on FDA regulations, including registrations.
Clients from all over the world trust me to quickly and competently file their registrations.
Any registration, any time, at flat fees.
Growing and maintaining a business is a lot of work.
As an entrepreneur and small business owner, I understand the demands on client’s time.
That’s why I aim to be responsive and efficient.
You want to quickly register without any hassle.
I can help you do that.
Growing and maintaining a business is demanding, and navigating FDA regulations can feel daunting.
As an entrepreneur with over 15 years of experience handling hundreds of FDA registrations, I understand the value of your time and the need for a seamless process.
That’s why I focus on being responsive and efficient, ensuring you can quickly and competently register without hassle.
Clients worldwide trust me to guide them through the complexities of FDA requirements with flat fees and dependable expertise.
Let me handle your registration so you can focus on growing your business.
Usually, registration alone is not enough to claim a product or company is approved. An application like GRAS, NDI, or 510(k) may provide a regulatory basis for this claim, but even in these cases, the FDA has stated that “FDA Cleared” is the truthful and accurate claim.
If a claim is needed following registration, then “FDA Registered” is recommended.
Note: I will provide you with a certificate from my firm confirming the registration was filed.
No, the use of the FDA logo is a violation of trademark law and can also lead to an FDA enforcement action based on creating a false and misleading impression the FDA has approved or endorsed the product or company.
A U.S. Agent must be appointed and listed in any foreign (non-U.S.) facility establishment registration.
The FDA regulations require registration within 30 days of entering the market.
If you’re at an early stage of development there’s no benefit to registering early, in particular, if a filing fee is required.
For most registrations, renewals are required at the beginning of each new Federal Fiscal Year, which is October 1.
The deadline for filing a renewal is December 31. In some cases, like food facility registrations, renewals are set to a biannual cycle.
It will depend on the circumstances, like if there’s an import hold that requires registration for a shipment to be released and the type of registration.
Typically, if there’s no urgency and an FDA filing fee is required, then filing an initial registration 30 or 60 days before renewal is required isn’t recommended because the FDA won’t prorate the user fee.