Quality Systems

Compliance Insight possesses the blend of scientific knowledge and industry experience needed to handle all aspects of quality assurance. Our team has more than a century’s worth of combined expertise managing risk and offers a broad range of capabilities.

We can help you design, evaluate and improve quality control systems; perform clinical material audits; develop and implement best practices plans; improve existing policies and procedures; perform trend analyses; and create plans to meet strategic benchmarks. Our goal is ensure your products can be manufactured and marketed using the safest and most cost-effective methods possible.

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

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