Confidentiality of your projects and protection of your intellectual property

PROTEODYNAMICS guarantees the strict confidentiality of customer’s projects and data. Each party remains the owner of materials, know-how and other information that was in its possession prior to initiation of collaboration. Results of the study belong in their integrity to the customer.

Quality

Our services are performed in compliance with the OCDE Good Laboratory Practice (GLP) standards. Results of our studies have been submitted to and accepted by several international regulatory authorities including EMEA and FDA.

Our Quality system is based on the following principals:

• Traceability of samples
• Quality trained scientific staff
• Controlled materials and qualified calibrated equipment and laboratory space
• Validated analytical and experimental procedures
• Editing of intermediate and final reports
• Quality control
• Document archiving

PROTEODYNAMICS’ quality system assures transparency of our services and studies from the planning stage, through execution of the actual project to reporting of the results. Study results can directly be integrated into our customer’s documentation for drug authorization.

Our studies are performed according to international guidelines, such as notably ICH Q6B or EMEA/CHMP/BWP/157653/2007 concerning the characterization of monoclonal antibodies and related products.