Portfolio of Services

Regulatory Training

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

Auditing Services

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

Computer System Validation (CSV)

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)

Quality Management System (QMS) Optimization

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)

Continuous Improvement Initiatives

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.

General Compliance Consulting

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.