• Site Management and Monitoring
• Data Collection, Processing, and Management
• Report, Abstract, and Publication Support
• Biostatistics
• Preclinical Services
• Project Management
• Regulatory
• FDA Inspections
• Electronic Data Capture
• Anatomic & Physician Training

Regulatory

The Integra Group's consultants have submitted over 100 IDEs, 510(k)s, and clinical study reports. We can provide clinical and regulatory support to assist you with writing reports of prior investigations, investigational plans, progress reports and PMA submissions. Our team also has experience with MDR reporting and post-market launch of products.