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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
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