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REALTIME FDA™ / U.S. RESPONSE
RealTime
FDA™.
Local expertise.
Timely action.
On-the-ground U.S. regulatory support for FDA issues during import clearance and
distribution.
Review Clarify Coordinate Support
01 / REALTIME FDA
Understand
the notice.
U.S.-based regulatory response when issues arise.
01 / FDA
FDA Notices & Corrective Actions
Review FDA Notices, including Notices of Action and Import Refusals, and explain their causes and implications.
Advise on corrective actions based on FDA’s findings.
02 / REALTIME FDA
Clarify
the next step.
Direct communication on compliance matters.
01 / FDA
FDA Communication & Requests
Communicate with FDA officers by phone or email to clarify issues and confirm next steps. Submit clarification or
appeal requests when an FDA action appears unreasonable or unclear.
03 / REALTIME FDA
Coordinate
on the ground.
Localized support during clearance or distribution.
01 / FDA
Importers, Brokers & Distributors
Coordinate with U.S. importers, brokers, or distributors for swift on-the-ground response to FDA-related issues
during customs clearance or distribution after export to the United States. Our U.S.-based experts help address
issues and minimize delays, refusals, or penalties.
02 / FDA
Retailer & Buyer Document Requests
Assist with FDA-related document requests from retailers or buyers, including registration status and listing
numbers.
04 / REALTIME FDA
Know
your coverage.
Clear service terms. Continued support.
01 / FDA
Six Months with MoCRA Services
RealTime FDA™ is included free of charge for six months with any of our MoCRA services. For an additional six
months of coverage, contact us to purchase an extension separately.
02 / FDA
Additional Regulatory Work
Additional regulatory actions requested by FDA, such as facility registration, label revisions, or product testing,
are billed separately.
CONTACT US
Plan your
next step.
Tell Provision Consulting Group about your FDA-related issue or ask about RealTime FDA™ coverage.