US FDA Agent Services
US FDA Agent Services
In the ever-important pharmaceutical and medical devices industry, a US FDA Agent Services plays a pivotal role, ensuring that every aspect of drug and device manufacturing, storage, and handling adheres rigorously to strict standards, safeguarding public health USFDA Agent Representation must.
Navigating the regulatory landscape can be challenging, but with RABT Global by your side, you gain a trusted partner to navigate the intricate FDA requirements. Whether you are a manufacturer or a distributor, appointing a US Agent for Pharmaceutical and Medical Device is a crucial step towards compliance.
As a leading provider of US FDA Agent services, RABT Global understands the critical mission of promoting and safeguarding public health. Operating under the umbrella of the US Food and Drug Administration (FDA), we are dedicated to regulating a diverse range of products, pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, and radiation-emitting products.
At RABT Global, we recognize the paramount significance of a competent and reliable FDA Agent in guaranteeing adherence to regulations and upholding the highest standards of public health.
Our US FDA Agent services encompass a wide range of responsibilities, such as:
- Comprehensive Inspection
- US Agent for Pharmaceutical and Medical Device
- Investigating Compliance
- Enforcement of Standards
- Consumer Complaint Resolution
- Compliance Oversight
- Facility Registrations
- Support in 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)
Ensure compliance, protect public health, and partner with RABT Global for expert US FDA Agent services. Contact us today to learn more about how we can support your business.
