Our Services

Providing in-person and webinar-based training on wide range of topics including but not limited to: 

• GLP Training and Refresher Training for CROs, Sponsors, and Laboratories
• Computer System Validation (CSV) Training
• Data Integrity and Good Documentation Practices 
• Bespoke training topics for your organization's needs

Comprehensive audits of systems, processes, and studies for compliance with regulatory requirements designed to strengthen inspection readiness and promote continuous improvement opportunities. Auditing capabilities include but are not limited to:

• Contract Research Organizations (CROs)
• Contract Laboratories
• Specialized Laboratories
• Bioanalytical Laboratories
• Central Laboratories
• Electronic Trial Master Files (eTMFs)
• Software Providers 
• Computer Validation Audits

Providing tailored computer validation support services for your organization and/or system including the development of key artifacts such as: 

• Validation Plan
• User Requirements Specifications
• Configuration Specifications
• Testing Documentation
• Validation Reporting
• Traceability Matrix
• Periodic Review(s)
• Change Control(s)

Comprehensive gap assessment, design, and implementation of quality management systems aligned with regulatory requirements. Services include but are not limited to:  

• Development of Standard Operating Procedures (SOPs) and Forms
• Development of organizational tools to support compliant, inspection-ready operations
• Creation and/or review of workflows to support electronic systems
• Due diligence assessments of QMS platforms (e.g., SaaS providers)

Robust initiatives focused on identifying improvement opportunities, enhancing process efficiencies, and reinforcing compliance through practical and sustainable solutions. Ongoing support provided to strengthen regulated quality systems and processes. 

Comprehensive consulting services including quality system development, regulatory compliance, computer system validation, regulatory training, and continuous improvement within organizations. Solutions are practical, scalable to meet organizational needs, and aligned with regulatory requirements.  We work with you to develop policies and procedures that align with your business goals and help you build a strong and productive workforce.