FDA Audits

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

  • Laboratory Audits

  • Due Diligence

  • Contract Manufacturer/Vendor Audits

  • GXP Gap Analysis Audits

  • Part 11 Compliance Audits

  • Clinical Trial Investigator Site Audits

  • Contract Research Organization Audits

  • IRB Audits

  • Clinical Site Audits

  • CRO Audits

Experience & Capabilities

  • FDA Compliance Consulting

  • Project Management

  • FDA 483 / Warning Letter

  • Consent Decrees

  • Systems Monitoring

  • GXP Training

  • Product Submissions

  • Due Diligence

  • Product Reviews

  • Registration & Listing

  • Audits

  • Gap Analysis

  • Regulatory Strategies

  • Inspection Preparation

  • GMP Services

  • GCP Services

  • FDA Submissions

  • Clinical Development

  • Nonclinical Development

  • Risk Based Assessment

  • Combination Products

  • Staff Augmentation

  • Electronic Publishing

  • Program Design

Gain Our Insight