GLP certification

With its abundant knowledge and experienced multi-disciplinary team, Kinesis Pharma is actively involved in supporting CROs to obtain endorsement of Good Laboratory Practice (GLP) compliance (“GLP certification”). Various activities are carried out for CROs such as establishing a standard in accordance with the international OECD GLP non-clinical drug safety evaluation platform focusing on the QA systems in all disciplines relevant for toxicological evaluation of compounds. The services that we offer to obtain GLP endorsement (“certification”) include writing Standard Operating Procedures (SOPs), training personnel,providing support in writing study plans and reports and preparation for inspections. Kinesis has broad experience with computerized system validation and the coordination of multi-site studies with CROs located in different countries. Kinesis performs on-site audits at CROs world-wide on a regular basis.

 

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Consultants in drug development

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