Quality Services
What quality issues are delaying the release of your product?
Of all the regulatory risks in the Life Sciences Industry, addressing quality compliance issues is one of the greatest sources of frustration for Medical Device, Biotech and Pharmaceutical Companies. 
Working in areas such as Corrective and Preventive Action (CAPA) management or responding to FDA 483 observations is extremely challenging because the process of identifying and rectifying these issues are extensive if you do not have the on-demand resources and talent required.
Eliassen Group Life Sciences Consulting supports clients in this area by providing the subject matter expertise needed to maintain quality compliance throughout the product development lifecycle.
Practice Areas
- Corrective and Preventative Action (CAPA)
- FDA 483 Observations
- Auditing and Gap Analysis
- Methods and Process Validation
- Supplier Assessment, Management and Improvement
Our dedicated team of consultants will deliver the resources and expertise required to efficiently advance your product to the market safely and efficiently.
Areas of Expertise
QE (Quality Engineering)
- Quality engineering
- Validation engineering
- Statistics / six sigma
- SQE – supplier quality engineering
QMS (Quality Management Systems)
- Interim managers and directors
- Quality systems
- CAPA – Corrective And Preventative Action
- Compliance Audit – internal and external
- Supplier Quality Management and audits
SW QA (Software quality assurance)
- SW Validation / QA
- Manufacturing systems / automation
- Automated document management