Compliance and Auditing

NaviGo can provide you with compliance and auditing services for your preclinical and clinical research trial(s) for FDA and global agency submission. Preliminary and interim compliance assessments can detect gaps and give you an edge on trouble-shooting. We can provide creative solutions for research issues and compliance maintenance essential for marketing your product under agency requirements.

Key Clinical/Preclinical Compliance services include:

• Sponsor Audits/Assessments
• Investigator and Investigational Site Audits
• Vendor/Supplier Qualification Assessments for Clinical & Preclinical
• Merger/Acquisition Assessments or Audit in relation to pre and Post Due Diligence
• General Compliance Needs for Clinical Trials-Global
• Clinical Business System Audit
• Prep and Assistance with FDA inspections
• Quality Assurance for Clinical Divisions
• FDA Responses to Clinical Inspections-Sponsor and Investigator
• CAPA for Clinical
• Investigational Site, IRB/EC Issues
• Risk Management of Clinical Compliance Problems
• Mock FDA Sponsor location Inspections
• Mock FDA Site Inspections
• Investigator-FDA Mock Inspections and Prep
  
• Monitoring Clinical CAPA and Management Review Audits