Whether you need assistance with submissions, with regulatory filings, or with crafting language appropriate to specific pharmaceuticals, substances or devices, Compliance Insight has the depth of knowledge to advance the approval process through the FDA’s regulatory process.
Our team provides an array of services, from training to preclinical evaluations to meeting reporting deadlines. We deliver world-class service, and will be an impactful strategic partner in new product launches and throughout your product’s development cycle.
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