Pharmaceutical Advisors
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Our Focus

Practical Quality Systems and Regulatory Advice

What we do and how it's different:

  • Operations oriented Quality perspective, not just "ex-FDA..."
  • Practical approaches to regulatory compliance
  • Cost-effective, proactive compliance

Examples of recent projects:

  • Establishment of appropriate cGMP systems for a research based company moving to commercial development
  • GAP Analysis and Action Plans following FDA Warning Letter
  • Vendor Audits that strengthen the vendor / client relationship
  • CGMP Gap Analysis and Action Plan
  • Pre-Approval Inspection Readiness Assessment