.png){kind=logo}
SMART ENTRY / U.S. REPRESENTATION
Smart Entry
Service.
At the border.
A local connection.
U.S. representation for all product categories, helping prevent customs issues during
border entry.
Prepare Connect Respond Scope
01 / SMART ENTRY
Prepare
for the border.
Smart Entry Service.
01 / FDA
U.S. Representation
Smart Entry Service provides U.S. representation for all product categories, helping prevent customs issues
during border entry.
02 / SMART ENTRY
Connect
with local expertise.
Regulatory support on the ground.
01 / FDA
Import Clearance & Distribution
Our U.S.-based regulatory experts support businesses facing FDA-related issues during customs clearance or
distribution after export to the United States. Tell us about your product and entry plans to discuss the appropriate
service scope.
03 / SMART ENTRY
When an issue
needs a response.
Related support: RealTime FDA™.
01 / FDA
Notices, Corrective Actions & FDA Contact
RealTime FDA™ support includes review of FDA Notices of Action and Import Refusals, explanation of causes
and implications, corrective action advice based on FDA findings, and phone or email communication with FDA
officers. Clarification or appeal requests may be submitted when an action appears unreasonable or unclear.
02 / FDA
Local Coordination & Document Requests
Coordinate with U.S. importers, brokers, and distributors. Assist with FDA-related document requests from
retailers or buyers, including registration status and listing numbers, to help minimize delays, refusals, or
penalties.
04 / SMART ENTRY
Understand
the service scope.
RealTime FDA™ coverage and additional work.
01 / FDA
Related RealTime FDA™ Coverage
RealTime FDA™ is included free for six months with any of our MoCRA services. An additional six months can
be purchased separately. FDA-requested facility registration, label revisions, product testing, and other additional
regulatory actions are billed separately. Contact us to distinguish Smart Entry support from RealTime FDA™
coverage for your engagement.
CONTACT US
Plan your
next step.
Tell Provision Consulting Group about your product, import plans, and U.S. representation needs.