For non-US pharmaceutical and life sciences companies, appointing a US Agent is a regulatory requirement for interaction with the US FDA. Our US Agent Support services provide reliable, compliant, and responsive representation for organizations submitting DMFs, ANDAs, NDAs, INDs, and other FDA regulatory filings.
We act as your authorized US FDA point of contact, ensuring seamless communication, regulatory responsiveness, and inspection readiness.
Comprehensive US Agent Services
Our US Agent support goes beyond designation—we actively manage FDA communications and regulatory obligations to support uninterrupted compliance.
Scope of US Agent Support Services
- Official US Agent Representation
- Appointment as US Agent for FDA registrations and submissions
- Representation for API, excipient, and finished dosage manufacturers
- Support for DMF holders and applicants
- FDA Communication & Liaison
- Primary contact for FDA correspondence
- Handling FDA letters, notifications, and information requests
- Coordination of responses with manufacturers and regulatory teams
- Timely escalation of critical regulatory communications
- DMF & Submission Support
- US DMF (Type II, III, IV, V) US Agent support
- ANDA, NDA, and IND submission coordination
- Letter of Authorization (LoA) management
- eCTD submission and lifecycle communication support
- FDA Inspection & Compliance Support
- Support during FDA inspections and follow-ups
- Assistance with inspection notifications
- Coordination for post-inspection correspondence
- Compliance communication and documentation tracking
- Ongoing Regulatory & Compliance Assistance
- Support for annual updates and amendments
- Change notification coordination
- Confidential handling of regulatory data
- Long-term regulatory relationship management
Regulatory Requirements Covered
Our US Agent services are aligned with:
- US FDA Regulations
- 21 CFR Parts 207, 210, 211
- US FDA DMF Guidance
- eCTD & ESG Submission Requirements
- ICH Q-series Guidelines
This ensures full compliance with US FDA expectations.
Why US Agent Support Is Critical
The US FDA requires a designated US Agent to:
- Serve as the official communication channel
- Facilitate regulatory correspondence
- Support inspections and enforcement actions
- Ensure rapid response to FDA requests
Failure to maintain an effective US Agent can lead to delays, missed communications, or regulatory non-compliance.
Why Choose Our US Agent Support Services?
- Experienced FDA Liaison
Strong understanding of FDA processes and communication protocols. - Prompt & Reliable Communication
Time-critical FDA messages handled without delay. - Confidential & Secure Handling
Protection of proprietary regulatory information. - Integrated Regulatory Support
Seamless coordination with DMF, eCTD, and compliance services. - Long-Term Partnership Approach
Support beyond submission—throughout the product lifecycle.
Industries We Support
- API Manufacturers
- Pharmaceutical Formulation Manufacturers
- Excipient Manufacturers
- Contract Manufacturing Organizations (CMOs)
- Export-Oriented Pharmaceutical Companies
- Start-ups Entering the US Market
Your Trusted US Regulatory Representative
Navigating US FDA requirements requires timely communication, regulatory clarity, and local representation. Our US Agent Support services ensure your organization remains compliant, responsive, and confident in all FDA interactions.
