FDA COMPLIANCE. HUMAN ACCOUNTABILITY.

Your products.
Your ambition.
Your FDA team.

An accountable partner for FDA compliance and import readiness. We manage the paperwork, coordinate the process, and keep you clear on what comes next.

For consumer brands, manufacturers, and importers.

Unbranded cosmetic product bottles ready for labeling

BUILT FOR THE PRODUCTS YOU BRING TO MARKET

One point of contact.
A clear path forward.

Built around your businessBrands entering the U.S.Growing product portfoliosManufacturers & importers

WHAT WE HANDLE

FDA paperwork is a process.
We help you own every step.

01 / ESTABLISH

FDA compliance
& documentation

Understand what applies to your products and get the right information in place.

Requirements and document assessment
Registration and listing coordination
Label and product review coordination
Cosmetics and MoCRA support

02 / PREPARE

Import readiness
& coordination

Connect your compliance work to the documents and people involved in your shipment.

Supplier documentation collection
Shipment paperwork checks
Applicable FDA filing coordination
Customs broker and partner follow-up

03 / MAINTAIN

Ongoing compliance
& follow-through

Keep track of the work after the first filing, as your products and business change.

Renewal and deadline management
Product and facility updates
Organized compliance records
Issue tracking and next-step coordination

Every engagement starts with a defined scope. Requirements and available support depend on your product category and business.

A SERVICE WITH SOMEONE BEHIND IT

You shouldn’t have to
chase the next step.

You need more than a list of requirements. You need someone to organize the work, follow up on missing information, and keep the process moving.

A named point of contactDefined deliverables and deadlinesClear progress and open questions

HOW WE WORK

Start with your product.
Leave with a plan.

Tell us what’s ahead.

Share your product category, where you manufacture, and what you’re preparing to launch, import, or update.

Agree on the work.

We define the requirements to assess, the documents needed, responsibilities, deliverables, and fees.

Put it in our hands.

We manage the agreed work and coordinate with you and your partners, with clear updates along the way.

A FEW THINGS TO KNOW

Clear from
the beginning.

Is Regbee software or a managed service?

Regbee is a managed service. You engage a team to handle agreed compliance tasks and coordination, with clear deliverables and a point of contact.

Can you help with cosmetics and MoCRA?

Cosmetics and MoCRA are part of our service focus. We begin by assessing your products and business so the scope reflects the requirements that apply to you.

Do you replace our customs broker?

No. Regbee coordinates FDA-related documentation and import readiness alongside your customs broker and other partners. Each party’s responsibilities are agreed before work begins.

Can you guarantee FDA approval or shipment clearance?

No. Regbee manages agreed work and coordination. Regulatory decisions and shipment clearance remain with the relevant authorities, and legal responsibilities remain with the applicable businesses and parties.

How is an engagement priced?

We quote based on your products, the work required, and whether you need a one-time project or ongoing support. Scope and fees are agreed before we begin.

LET’S GET THE WORK MOVING

What’s next
for your products?

A launch, a shipment, or paperwork that needs attention.
Tell us where you are. We’ll discuss the next steps.

Your products.Your ambition.Your FDA team.

FDA paperwork is a process.We help you own every step.

FDA compliance& documentation

Import readiness& coordination

Ongoing compliance& follow-through

You shouldn’t have tochase the next step.

Start with your product.Leave with a plan.