Prescribing Solutions
The associates at Compliance Insight know that breakthroughs in pharmaceuticals are good for everyone. That’s why we work so hard to bring your work from the bench to the bedside.
We bring in-depth experience in Pharmaceutical regulatory consulting, product development, and quality systems services to developers and manufacturers of pharmaceutical products. We apply our insight at every stage of the compliance process; delivering solutions that broaden treatment options and help improve patient health.
Select Services & Capabilities
GRASE Evaluations
Drug Classification
Prepare Drug Facts Panel
Agency Relations
Compliant Draft Labels
Drug Applications (ANDA)
Due Diligence Assessments
Regulatory Strategy
FDA and Advisory Meetings
Author, Review and Publish Applications and Amendments
Nonclinical Pharmacology and Toxicology
Safety Assessments
Nonclinical CRO selection
Oversight Reports
Phase 1 – 4 Clinical Protocol Development