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"Quality is never an accident; It is always the result of
high intention, sincere effort, intelligent direction and skillful execution; It represents the wise choice of many alternatives"
Our Services

quality
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QMS/eQMS Implementation and/or Management
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Risk Management
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CAPAs
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Training
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Audit Execution (MDSAP, EU MDR, ISO 13485:2016, QMSR, Sterilization, etc.)
REGULATORY
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Strategies
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Submissions
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Remediation
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Compliance
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EU MDR and QMSR Transitions
technical services
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Technical writing
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Validation, Verification and Qualification Plans
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Statistical Analyses
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Test Laboratory Sourcing
clinical
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Site Qualification
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Site Monitoring
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Study Audits
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TMF/eTMF Preparation and Maintenance
project management
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Project Planning
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Plan Execution
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Resource Allocation and Management
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