FDA compliance does not end after a product receives clearance or approval. Companies must actively manage post-market surveillance to ensure ongoing safety, effectiveness, and regulatory compliance. Failure to meet post-market obligations can lead to recalls, penalties, import alerts, and reputational damage.

At XPRO AMERICA, we provide comprehensive post-market surveillance and compliance services that enable businesses to meet FDA requirements while maintaining consumer trust. From periodic safety updates to adverse event monitoring, our experts ensure your products remain compliant throughout their lifecycle.

Key Services:

• Periodic Safety Updates: We help companies prepare and submit periodic safety reports to the FDA, demonstrating continuous monitoring of product performance and safety.
• Adverse Event Monitoring: Our team establishes systems for Medical Device Reporting (MDR) and pharmacovigilance, ensuring timely detection, evaluation, and reporting of adverse events in line with FDA requirements.
• FDA Recall Management: In cases where misbranded, adulterated, or unsafe products must be withdrawn, we develop recall strategies and liaise with the FDA to minimize business and consumer impact.
• Compliance with 21 CFR Requirements: Whether for pharmaceuticals, medical devices, dietary supplements, or cosmetics, we ensure adherence to applicable post-market regulations and reporting standards.
• Risk Management & CAPA Support: We help companies identify post-market risks, implement Corrective and Preventive Actions (CAPA), and strengthen systems to prevent recurrence of issues.
• Global Market Monitoring: For international companies exporting to the U.S., we provide guidance on integrating global post-market data with FDA-specific compliance requirements.

Why Choose XPRO AMERICA?

• Expertise across multiple FDA-regulated industries, including drugs, devices, supplements, and biologics.
• End-to-end support, from safety monitoring to recall execution.
• Proactive strategies to reduce compliance risks and maintain FDA trust.
• Tailored solutions for both U.S. and foreign manufacturers.

With XPRO AMERICA’s post-market surveillance services, companies can maintain long-term FDA compliance, protect consumer safety, and safeguard brand reputation. Our structured approach ensures that every regulatory obligation is met with accuracy and efficiency.

XPRO AMERICA ensures FDA post-market compliance with safety updates, recall management, and adverse event monitoring for regulated products.