Qualidea provides the following services:


GCP: Every phase of a clinical trial: clinical trial protocol, laboratories, clinical investigator sites/institutions, pharmacies, statistics, data management, clinical trial report

GLP: Every phase of a preclinical trial: protocol, laboratories, test facilities, test sites, statistics, data management, preclinical study report

GMP, Medical devices, ISO 9001 and ISO 13485: Quality systems 

Audits of your Quality systems

Audits of your subcontractors/vendors

Standardized Operating Procedures

  • Training of principles, reviews, writing and management
  • Reviews of existing procedures and practices
  • Writing of your SOPs

Quality Consultancies

  • Discussions with the management, guidance in quality and QA processes
  • Supporting in quality thinking and implementation of
    • Continuous improvement
    • CAPA processes
    • Change management
    • Risk management
    • Business continuity
  • When building a Quality Management System, evaluations of the quality needs of the company
  • Evaluations of existent Quality Management Systems
  • simplifying of your quality systems and quality documentation
  • Inspection readiness audits and evaluations
  • Ongoing support in your quality practices

Training of the personnel

  • Tailored training with practical examples and discussions

Assistance in your projects other than QA/Quality function

Sometimes you might have situations where you need additional short-term help outside the quality function. Qualidea could help in e.g., reviewing/organizing your documentation.