Mindlance Clinical’s Regulatory and Validation Compliance Consulting Practice provides services in quality systems and compliance for both project based needs or staffing of specialists to augment your team or fill niche subject matter expertise.

Due to the criticality of balancing regulatory needs, implementing effective practices, ensuring quality throughout the life cycle, validation for systems, and GMP/QSR compliance, organizations are taking a more comprehensive view of compliance and Mindlance Clinical can help. In addition, the enhanced pressure by regulatory agencies surrounding system compliance with regulations such as 21 CFR Part 11 and GCP’s increase the need for organizations to ensure validation. Non compliance and the reinvigoration of oversight programs by the FDA and NIH could result in delays costing sponsor companies millions of dollars or could even result in the suspension of trials.

Mindlance Clinical’s team has extensive experience in building teams for on-site and off-site assignments designed to lead and support compliance and validation initiatives. Whether we are assisting a client by helping them augment their existing team through staffing services or building a highly qualified team to support an outsourcing effort, Mindlance Clinical’s focus is on bringing the right level of talent to bear on your projects.

Our Offerings:

Validation

• Consultation
• Strategy & Program Development
• Assessments
• Master Planning
• Protocol Development & Execution
• Software/21 CFR Part 11
• Equipment
• Program Outsourcing

Compliance & Quality Systems

• Consultation
• Regulatory Gap Analysis
• Program Development
• GMP/QSR
• FDA Readiness Audit
• Planning, Implementation & Training

Clinical Study Compliance

• GLP Assessments
• GCP Compliance Assessments
• Clinical Investigator
• Sponsor
• Monitor
• Central Study File
• Database and Data Mgmt
• Institutional Review Board

Capabilities:

• Validation Projects or Staffing
• Clinical Systems Risk Assessment
• Validation Project Management
• 21 CFR Part 11
• Test Script Creation & Execution
• Quality & System Audits
• Training & Education Programs
• HIPAA
• Sarbanes-Oxley