Services
Succeeding in today’s dynamic regulatory environment requires that each medical device or pharma business be statutorily fluent yet practical regarding their compliance/regulatory affairs and quality systems. Click on an item below to learn more about ComplianceAcuity's realistic, proven solutions in either area.
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 / Product Development
- Risk Management
- GMP Training
- Internal/Mock Audits
- Management Responsibility
- Production and Process Control