Compliance Insight specializes in helping businesses in the pharmaceutical medical device, and biologic industries navigate the FDA regulatory process. We offer an extensive suite of capabilities, and are able to develop impactful strategic plans that bring products to market quickly and efficiently.
Our expert network of consultants posses a deep knowledge of FDA practices. We have helped hundreds of life science professionals achieve and maintain FDA compliance, and routinely address needs that include: product submission, GXP training, clinical and nonclinical development, program design, product evaluation, and system monitoring.
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