Compliance Insight provides a variety of FDA audit risk assessment and evaluative services. Our team of specialists is available to review facility and supply chain capabilities, management expertise, technology, and process controls, documentation, and legal filings.
We can generate detailed assessments of your existing quality systems, identify current and potential FDA Audit risk factors, and recommend corrective measures. We leverage our FDA Regulatory expertise to determine your risk and help you institute best practice systems that ensure across the board compliance.
Our FDA Audit Services enable you to take a proactive approach to quality assurance and regulatory compliance. Services include:
PAI Preparation/Mock Audits
Contract Manufacturer/Vendor Audits
GXP Gap Analysis Audits
Part 11 Compliance Audits
Clinical Trial Investigator Site Audits
Contract Research Organization Audits
Clinical Site Audits
Experience & Capabilities
FDA Compliance Consulting
FDA 483 / Warning Letter
Registration & Listing
Risk Based Assessment