US FDA Agent Services

In the ever-important pharmaceutical and medical devices industry, a US FDA Agent plays a pivotal role, ensuring that every aspect of drug and device manufacturing, storage, and handling adheres rigorously to strict standards, safeguarding public health. At RABT Global, we understand the critical mission of promoting and safeguarding public health. We regulate a diverse range of products — including pharmaceutical drugs, vaccines, biopharmaceuticals, medical devices, and radiation-emitting products. Appointing a US Agent for Pharmaceutical and Medical Device is a crucial step towards compliance.

Our Services Include:

Comprehensive Inspection
US Agent for Pharmaceutical and Medical Device
Investigating Compliance
Enforcement of Standards
Consumer Complaint Resolution
Compliance Oversight
Facility Registrations
Submission of Control Correspondences
Managing US FDA Communications for the Applicant
Support in FDA Application Filings/Follow-Ups
Support in Deficiency Responses Submissions
Submission of Self–ID for Manufacturing Site
Support in Site/Facility/Establishment Registration
Filing of Suitability Petition and Citizen Petition
Support in Product Labelling (eDRLS)
No Blanket Registration
Submission of Drug Listing (CARES ACT)

Ready to Ensure Compliance and Protect Public Health?

Partner with RABT Global for expert US FDA Agent services tailored to your pharmaceutical or medical device needs.