Quality assurance
At Neuvantics, we ensure that all projects adhere to the highest standards of quality through a comprehensive, risk-based approach to quality assurance. Our dedicated Quality Assurance (QA) team operates independently, fostering a culture of excellence by ensuring strict compliance with established processes, applicable regulations, and industry standards such as Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP). This begins with the development and implementation of company-wide quality assurance policies and a robust Quality Management System (QMS) that governs all aspects of our work. By applying this framework, we are able to identify potential issues early in the process, enabling proactive intervention and the implementation of corrective and preventive actions (CAPA) to address and prevent recurrence, while supporting continuous improvement.
We place a strong emphasis on training, both for new hires and veteran employees, to ensure that the value of quality is deeply embedded across the organization. Our mandatory training programs cover a wide range of critical topics, including Corrective and Preventive Action Plans (CAPA), Good Clinical Practice, Human Subject Protection, and the identification and management of fraud and misconduct. Beyond these essential areas, our Quality Assurance services extend to conducting internal audits, monitoring the effectiveness of corrective actions, and maintaining comprehensive documentation to ensure compliance at every stage of the clinical trial process. Our proactive, continuous training, and rigorous monitoring processes ensure that Neuvantics upholds the highest standards of quality, compliance, and patient safety in every project we undertake.
Our quality assurance services include:
- Auditing and compliance assessments for GCP and GMP, including vendor, clinical site, and computer system evaluations (due diligence)
- eTMF (electronic Trial Master File) auditing
- Development and adherence to Standard Operating Procedures (SOPs)
- Implementation of Quality Management Systems (QMS)
- Risk management strategies and assessments
- Consulting services for GCP and GMP compliance
- Training on regulatory compliance
- Preparation for inspections and conducting mock FDA inspections
- Supply Chain Management and related consulting
- Validation compliance for computer systems
- Regulatory education and training programs