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Home
Services
Compliance and Regulatory Affairs
FDA / Third-Party Audit Support
FDA 483, Warning Letters, Other Agency Citations
Liaison with Regulatory Agencies
Global Premarket Submissions
U.S. Agent
Adverse Event Reporting
Recalls and Safety Alerts
Ad/Promo Regulation
U.S. Import/Export
FDA Establishment Registration / Device Listings
Quality Management Systems (QMS)
Corrective & Preventive Action (CAPA)
Complaint Handling
Design Controls
Risk Management
GMP Training
Internal/Mock Audits
Management Responsibility
Production and Process Control
Testimonials
About Us
Blog
Contact Us
