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Quality Management Services 

At Trinity M Consulting, our Quality services are meticulously designed to support the stringent demands of the pharmaceutical, biotech, and medical device industries. We provide comprehensive services and solutions to support products meet the highest standards of quality and compliance.

1

Quality Management Systems (QMS) Implementation

  • QMS implementation  aligned with international standards, such as ISO 9001, ISO 13485, MDSAP, and FDA QMSR.

  • Custom QMS Design. 

  • Gap Assessments. 

  • QMS Continuous Improvement. 

  • QMS Training. 

2

Document Management

  • Industry Templates for QMS implementation and maintenance. 

  • ​Template Customization. 

  • Template Integration.

  • Document Control Systems. 

3

Internal Audits

  • Comprehensive Internal Audits. 

  • Corrective Action Plans. 

  • Non-conformances. 

  • Complaint Management. 

  • FDA Warning Letter Support. 

  • Recalls Management. 

Trinity ReguMed Insight 

Trinity ReguMed Insight is a Regulatory Cloud Application, designed to capture regulatory and quality information for the medical device, biotechnology, and pharmaceutical industry. 

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