
Quality Systems
POLICIES, PRACTICES, PROCESSES
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
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FDA Compliance Consulting
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Project Management
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FDA 483 / Warning Letter
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Consent Decrees
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Systems Monitoring
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GXP Training
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Product Submissions
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Due Diligence
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Product Reviews
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Registration & Listing
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Audits
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Gap Analysis
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Regulatory Strategies
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Inspection Preparation
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GMP Services
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GCP Services
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FDA Submissions
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Clinical Development
- Nonclinical Development
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Risk Based Assessment
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Combination Products
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Staff Augmentation
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Electronic Publishing
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Program Design