IRC was one of the first consulting organizations to offer this important and required service to foreign manufacturers of medical products. Clients that we have and continue to represent range from Europe through Asia. With years of experience and understanding of various cultures, languages and practices, we have proven our capability in a multinational environment to effectively relate requirements of the U.S. Food and Drug Administration to our clients.
In addition to the basic fundamental service as U. S. Agent we offer a variety of options which can be tailored to fit the needs of our clients.
FDA U.S. AGENT/OFFICIAL CORRESPONDENT SERVICES
- Annual Basic Representation
- Annual Facility Registration & Listings
- Clinical Trial Representation - required
- Medical Device Reporting Complaint Handling Management
- Coordination with US Importer/Distributor
- QSR / GMP & Regulatory Systems Analysis/Auditing
- 510(k) / PMA / IDE Submissions
- NDA / ANDA / IND Submissions
- FDA Inspection Coordination
- Strategic and Regulatory Planning
- Personnel Training