Overview
Regulatory compliance isn't a one-time event—it requires ongoing vigilance. Our compliance monitoring service keeps track of your FDA obligations, registration status, and relevant regulatory changes that could affect your US market access. We proactively alert you to upcoming deadlines, new requirements, and enforcement trends so you're never caught off guard. Think of us as your regulatory early warning system.
Key Features
Our Process
Baseline Assessment
We establish your current compliance status and document all ongoing obligations.
Monitoring Setup
We configure monitoring for your specific products, establishment, and regulatory requirements.
Ongoing Surveillance
We continuously monitor FDA databases, Federal Register notices, and enforcement actions.
Reporting & Alerts
We provide regular compliance reports and immediate alerts for significant developments.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Proactive awareness of regulatory obligations
- Zero missed deadlines or renewals
- Early warning of enforcement trends in your space
- Understanding of new requirements before they take effect
- Documented compliance status for audits
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Request a personalized consultation and detailed information about this service.
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Ready to get started?
Contact our team to discuss your specific needs for Compliance Monitoring.
Schedule ConsultationWhat Our Clients Say
"Adelphi alerted us to a new FDA guidance that would have affected our labeling. Because we had advance notice, we were able to update our labels before the compliance date. That's the kind of proactive service that prevents problems."
Dr. Ingrid Berg
Head of Regulatory
Scandinavian Pharma
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FDA Liaison Services
We serve as your designated US Agent and official FDA liaison for regulatory communications.
Establishment Registration
Complete support for FDA FURLS registration, annual renewals, and drug listing requirements.
Communication Management
Receipt and prompt forwarding of all FDA correspondence, including inspection notifications.