Quality Assurance
Quality Standards
Alphalyse A/S operates one Quality Management System which has been designed to satisfy the requirements of Good Laboratory Practice (GLP). All studies are performed to this same Quality Management System, whether they are intended for research and development or for submission to a regulatory authority. For regulatory studies and if so requested by Sponsor, the study is performed in compliance with the principles of Good Laboratory Practice and a claim of compliance to Good Laboratory Practice is made in the final study report.
Alphalyse A/S has been audited by the Danish Medicines Agency and holds a Test Site Authorization, confirming our compliance to Good Laboratory Practices.
The protein analysis services are conducted by trained and experienced personnel. All project information and results are recorded, documented, and stored. Protein identification database searches are conducted on updated in-house servers kept behind secure firewalls.
Clients are welcome to audit our facility upon request.
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