Assuring quality, assuring integrity
Quality Management Systems (QMS) and Quality Assurance (QA) activities are essential for the successful development of GxP compliant products. We offer a range of Quality Assurance services from early development to post-marketing. By insourcing one of our QA specialists to your premises, or outsourcing specific tasks, a strategic partnership with LINK Medical will give you access to services suited to your unique business needs.
A global team with local insights
Planning and carrying out product development requires extensive documentation to ensure reliable results and compliance with local and international regulations. Our team of QA professionals has broad experience from across the life science and health sectors, giving them the competence required to support you with any challenge.
Overview of Quality Assurance services:
Quality Management System (QMS)
- Develop and implement quality systems in pharmaceutical, biotech, and medical device companies
- Develop or revise QMS documents, including standard operating procedures (SOPs), quality manuals, and policies
We can help with projects ranging in size from the review of a single SOP to the setting up of a complete QMS. Our dedicated professionals have broad experience gained from quality assurance, quality control, and quality advisor positions within health authorities and the international pharmaceutical industry.
Our services can be performed at our site, at the customer’s premises, or with subcontractors. We can also take care of specific parts of your company’s internal processes. Let us advise you on the appropriate quality level for your organisation.
- Regulatory inspection readiness and response
- Pre-audits and pre-inspections
- Investigational site audits
- GCP, GVP GLP, GMP, and GDP compliance
Study specific Quality and Compliance assistance:
- Compliance questions/issues
- Investigational Products
- Quality checks of study deliverables
Other QA services:
- GxP Training
- Quality manager (outsourcing)
- Specific roles, e.g., Responsible person (RP) / RP support
To find out more about how our Quality Assurance services can ensure your documentation and processes meet all necessary regulatory requirements, please contact Hilde Ringstad, Director QA Operations, contact via email