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