Pharmaceutical Regulatory

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

Industry Expertise

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