Overview
FDA regulations require that US Agents be available during US business hours to respond to agency inquiries. For foreign establishments operating in different time zones, this can be challenging. Our US-based team provides guaranteed availability during all US business hours, ensuring that FDA can always reach someone knowledgeable about your establishment. We understand FDA's expectations and can handle initial inquiries professionally while coordinating with you as needed.
Key Features
Our Process
Contact Setup
We establish dedicated contact points for FDA and provide you with our availability protocols.
Staff Briefing
Our team is briefed on your establishment, products, and any special considerations.
Inquiry Handling
When FDA contacts us, we respond immediately and coordinate with you as appropriate.
Reporting
We log all contacts and provide you with regular reports of any FDA interactions.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Full compliance with FDA US Agent availability requirements
- No time zone barriers for FDA communications
- Professional representation to FDA on your behalf
- Immediate response capability for urgent matters
- 24/7 emergency contact for critical issues
Get More Details
Request a personalized consultation and detailed information about this service.
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for US Business Hours Availability.
Schedule ConsultationWhat Our Clients Say
"Having a reliable US-based team that's always available when FDA calls is essential for our business. Adelphi has handled dozens of FDA inquiries on our behalf, always professionally and promptly. They're a true extension of our team."
Chen Wei
International Business Director
Asian Pharmaceutical Company
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