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SERVICES

We serve as your external consulting partner for compliance readiness and remediation endeavors.

We offer top-tier consultants, quality experts, and advisors, all deeply committed to addressing your quality-centric challenges.

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  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
Validation and Lifecycle Management
  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
three people working and smiling
  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
three people working and smiling
  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
hand computer scale
  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
three hands with a paper
  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
six people working
  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
three hands pointing a target
  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
two people working on magnifying scales
  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
two women calculating
  • Regulatory Compliance
    On-Site and Virtual Third-Party and MOCK Audits FDA and Global Regulatory Agencies Compliance Assessments Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution Site Inspection Readiness & Enhancement Plans Third-Party Oversight: Oversight Protocols creation Oversight execution Metrics tracking & Reporting Mentoring Certification Compliance Management Strategies Data Integrity and DIRA (Data Integrity Risk Assessments) Quality Culture and Sustainability of Compliance Quality Key Behaviors Indicators (KBIs) Assessment/Development Quality Communications Plan Design Investigations Back-log resolution & CAPA’s Effectiveness Root Cause Analysis SOP’s Simplification Records Management & Document Controls System Management Storyboard creation and Improvement Scientific and Technical Assistance (Process, Laboratory, Packaging Operations) Quality Systems Enhancement: Analysis Streamlining Simplification Quality Management System Development
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