Key Deliverables
Comprehensive support tailored to your specific regulatory needs.
FDA Liaison Services
We serve as your designated US Agent, acting as the official liaison between your foreign establishment and the FDA for all regulatory communications.
Establishment Registration
Complete support for FDA FURLS registration, including initial registration, annual renewals, and drug listing requirements.
Communication Management
Receipt and prompt forwarding of all FDA correspondence, including inspection notifications, warning letters, and information requests.
Inspection Support
Coordination of FDA inspection scheduling and logistics, ensuring your establishment is prepared and responsive to agency requirements.
Compliance Monitoring
Ongoing monitoring of your registration status, renewal deadlines, and regulatory changes that may affect your US market access.
US Business Hours Availability
Dedicated availability during US business hours as required by FDA regulations, ensuring timely response to all agency inquiries.
Our Approach
A proven methodology designed to minimize risk and maximize speed to market.
Onboarding & Assessment
We evaluate your current FDA registration status, product listings, and compliance requirements to identify any gaps or issues.
Registration & Designation
We complete your US Agent designation through FURLS, ensuring all information is accurate and your registration is compliant.
Ongoing Management
We manage all FDA communications on your behalf, keeping you informed while ensuring timely responses to all inquiries.
Annual Renewal & Updates
We handle annual registration renewals, product listing updates, and any changes to your establishment information.
Ready to Accelerate Your Regulatory Success?
Contact us today to discuss your specific needs and how we can support your goals.