• 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

FDA Inspections

The Integra Group has extensive experience helping clients prepare for FDA inspections, both in-house and at study sites. Our consultants are available to train your sites and your staff on what to expect during an FDA inspection, provide an assessment of the state of compliance, help you organize critical documentation, raise awareness about potential questions that may arise during the inspection, and provide guidance on how to prepare for and respond to the FDA.